Collecting Blood and Tissue Samples in Paediatric Clinical Trials

2006 ◽  
pp. 59-64
Author(s):  
Sabine Fürst-Recktenwald ◽  
Marianne Soergel
Keyword(s):  
Clinical Trials ◽  
Tissue Samples

Utility of circulating tumor DNA (ctDNA) versus tumor tissue clinical sequencing for enrolling patients (Pts) with advanced gastrointestinal (GI) cancer to matched clinical trials: SCRUM-Japan GI-SCREEN and GOZILA Combined Analysis.

2020 ◽  
Vol 38 (4_suppl) ◽  
pp. 5-5 ◽  
Author(s):  
Yoshiaki Nakamura ◽  
Hiroya Taniguchi ◽  
Hideaki Bando ◽  
Ken Kato ◽  
Taito Esaki ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Tumor Tissue ◽  
Objective Response ◽  
Progression Free Survival ◽  
Circulating Tumor Dna ◽  
Tissue Samples ◽  
Combined Analysis ◽  
Clinical Sequencing ◽  
Gi Cancer

5 Background: Blood-based genomic profiling by ctDNA analysis has a promise to potentially identify actionable genomic alterations. However, utility of clinical sequencing with ctDNA compared with that with tumor tissue for enrolling cancer pts to matched clinical trials remains unclear. Herein we investigated the utility of ctDNA clinical sequencing by the SCRUM-Japan GI-SCREEN and GOZILA Combined Analysis. Methods: In the GI-SCREEN, tumor tissue samples of pts with advanced GI cancer were analyzed by a next generation sequencing (NGS)-based assay, Oncomine Comprehensive Assay since Feb 2015. In the GOZILA, plasma samples of pts with advanced GI cancer were analyzed by an NGS-based ctDNA assay, Guardant360 since Feb 2018. Tests were performed centrally by CLIA-certified and CAP-accredited laboratories. Pts with actionable alterations were enrolled to matched company-sponsored or investigator-initiated clinical trials. Results: As of Apr 2019, test results were generated in 5,029 out of 5,743 pts (88%) in GI-SCREEN and 1,089 out of 1,103 pts (99%) in GOZILA ( P < 0.0001).Median turnaround time (TAT) was 35 days in GI-SCREEN and 12 days in GOZILA ( P < 0.0001). There were no differences in other baseline characteristics between GI-SCREEN and GOZILA. Proportion of enrolling matched clinical trials in GOZILA was significantly higher than that in GI-SCREEN (126 pts [2.2%] in GI-SCREEN vs. 60 pts [5.4%] in GOZILA, P < 0.0001). Median time from GI-SCREEN or GOZILA enrollment to clinical trial enrollment was 5.9 and 1.0 months (mo), respectively ( P < 0.0001). The objective response rate (ORR) and progression-free survival (PFS) were not significantly different (ORR: 17.5 vs. 16.7%, P = 1.00; median PFS: 2.8 vs. 2.0 mo, P = 0.24). Conclusions: Clinical sequencing with ctDNA having the advantage of the shorter TAT enrolled more pts with advanced GI cancer to matched clinical trials than those with tumor tissue, without compromising the efficacy. Clinical trial information: UMIN000029315.

Progression-free survival in intention to treat populations versus total KRAS populations in patients treated for metastatic colorectal cancer: A pooled review

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 4054-4054
Author(s):  
B. A. Costello ◽  
J. R. Hecht ◽  
A. Grothey
Keyword(s):  
Colorectal Cancer ◽  
Clinical Trials ◽  
Progression Free Survival ◽  
Tissue Samples ◽  
Mutation Status ◽  
Free Survival ◽  
Intention To Treat ◽  
Pooled Data ◽  
Kras Status ◽  
Kras Mutation Status

4054 Background: In treatment trials of patients with metastatic colorectal cancer (mCRC), KRAS mutation status of tumor samples has been retrospectively demonstrated to be predictive of treatment benefit. Historically, clinical trials have not required tissue samples to be tested for KRAS mutation status as a condition of enrollment. Therefore, KRAS analyses have been based on available tissue samples representing only a portion of patients retrospectively analyzed for KRAS status and correlated with treatment end- points. Methods: A weighted analysis of pooled data was performed using six recently presented or published clinical trials of targeted therapy in mCRC which tested for the association of KRAS status with Progression Free Survival (PFS). The goal of the analysis was to determine whether there is a significant difference in PFS between the intention to treat (ITT) population and KRAS population in both the treatment and control arms. Results: The total ITT population of the pooled studies is 3864, and for the total KRAS population, 2295; a 59.4% retrieval rate (range 28–92%) for tissue samples available for KRAS analysis. The weighted Δ PFS across all arms between the ITT population and the KRAS population was 0.2 months with a range of 0–0.7 months. Of the 12 subgroups (6 control and 6 treatment arms), five had no difference in PFS between ITT and KRAS evaluable populations at all, and two additional subgroups demonstrated a difference PFS of only 0.1 months. The two studies with the lowest tissue retrieval rates (28% and 45%) had the largest Δ PFS. Conclusions: There is no meaningful difference in the PFS between the ITT and KRAS populations based on our analysis of pooled data. The difference in PFS was greatest in the two studies with the lowest rate of retrieval of tissue samples for KRAS testing. As such, subgroup analysis is better able to estimate and reflect the ITT population if a higher percentage of samples is able to be obtained. Further, our results suggest that there is not an inherent systemic bias influencing any potentially observed differences in PFS. Tissue samples should be required for all patients entering a clinical trial to avoid this issue and to make retrospective analysis more valid. [Table: see text]

scholarly journals Comparative Study of Tumor Biopsy and Ctdna to Support Patient Selection in Phase I Trials: The Gustave Roussy Single Center Experience in Aggressive B-Cell Lymphomas

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 1496-1496
Author(s):  
Anthony Tarabay ◽  
Jean-Marie Michot ◽  
Anne Aupérin ◽  
Julien Lazarovici ◽  
Julien Rossignol ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Board Of Directors ◽  
Gold Standard ◽  
Early Phase ◽  
Research Funding ◽  
Advisory Committees ◽  
Tumor Biopsy ◽  
Tissue Samples ◽  
Early Phase Clinical Trials ◽  
Tumor Biopsies

Patient's selection in early phase clinical trials is guided by stringent clinical criteria and can be supported or improved by precise tumor characterization and/or molecular stratification. Most of the precision medicine data are generated using historical tumor biopsies often collected before anticancer drugs treatment, which may thus only partially reflect the tumor's molecular landscape at inclusion in early phase clinical trials. The gold standard fresh tumor biopsy is not always feasible without risk for the patient. For this reason, ctDNA could be a simple, safe and attractive technique for obtaining critical information on the tumor genomic landscape. This study was designed to explore if whether NGS results obtained with from ctDNA could replace fresh tumor biopsies in patients (pts) at inclusion in early phase clinical trials. Data generated on both tissue samples collected in a short period of time in 52 pts treated for a B-cell aggressive lymphoma in the DITEP department at Gustave Roussy prior to inclusion were compared (18/52 pts had one course of chemotherapy between the 2 tissue samples). Characteristics at sampling were: mean age = 66 y.o., male/female: 32/20, Ann Arbor staging: 1/2/3/4 = 4 (7.7%), 5 (9.6%), 8 (15.4%) and 35 (67.3%) pts. The median number of prior chemotherapy was 2 (Min=1; Max=7). NGS tests were done using a panel of 39 genes and more recently 44 genes. 34 genes were found mutated in at least one pt. 150 mutations of pathologic significance were identified and 105 mutations out of 150 (70.0%) were concordant between the fresh biopsy and the blood (95%CI=62.0%; 77.2%). No patient had a mutation detected in the ctDNA analysis that was not found in the fresh tumor biopsy. In 8/52(15%) patients, no mutation was detected in both tumor biopsy and blood. Of the 44-remaining pts, 10 had no mutation detected in the blood and 34 pts (77.3%) carried at least one mutation detectable in both the tumor and blood. In 25/44patients (56.8%) all mutations identified in the tumor could be also detected in the blood (95%CI=41.0%; 71.7%), which are "informative ctDNA patients" if we consider that tumor biopsy is the "gold standard" as it is in clinical trials. Among the 44 pts that have at least one mutation detected in the tumor, the median VAF detection in the tumor biopsy was 41% (range 2-98%) and in the blood it was 7% (range 0-83%), but if we focus on the 105 mutations detected in both the biopsy and in the blood, the median VAF observed is 43% in the tumor (range 2-98%) and 14% in the blood (range 1-83%). Our results suggest that 85% of the pts included in phase I trials have at least one detectable mutation in the tumor biopsy, but approximately 50% of the pts have concordant mutations found in both ctDNA and fresh tumor samples. These results also suggest that ctDNA could be a useful tool in those "informative ctDNA" pts for residual disease assessment without sequential biopsies. Disclosures Ribrag: MSD: Membership on an entity's Board of Directors or advisory committees; Nanostring: Membership on an entity's Board of Directors or advisory committees; Gilead: Membership on an entity's Board of Directors or advisory committees; Incyte: Membership on an entity's Board of Directors or advisory committees; Infinity: Membership on an entity's Board of Directors or advisory committees; Roche: Other: Travel, accommodations, and expenses ; BMS: Membership on an entity's Board of Directors or advisory committees, Other: Travel, accommodations, and expenses ; Servier: Consultancy, Membership on an entity's Board of Directors or advisory committees; AZ: Membership on an entity's Board of Directors or advisory committees; ArgenX: Research Funding; Epizyme: Consultancy, Research Funding.

Are There Barriers to the Release of Paraffin Blocks for Clinical Research Trials? A College of American Pathologists Survey of 609 Laboratories

2011 ◽  
Vol 135 (7) ◽  
pp. 870-873
Author(s):  
Patrick L. Fitzgibbons
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Broad Spectrum ◽  
Market Research ◽  
Tissue Samples ◽  
Policies And Procedures ◽  
Paraffin Block ◽  
Single Block ◽  
Voluntary Market ◽  
Clinical Research Trials

Abstract Context.—The number of paraffin blocks submitted for patients enrolled in clinical research trials appears to be declining. Objective.—To obtain information on laboratory policies and procedures in complying with requests to submit paraffin blocks for research. Design.—A questionnaire was sent to members of a voluntary market research panel composed of pathologists representing a broad spectrum of experience and practice settings. The questions addressed departmental policies and the likely responses to requests to submit pathology materials for patients enrolled in clinical trials. Results.—The survey was completed by 609 of 762 pathologists (80%) who responded to the invitation. More than 90% of respondents stated that they comply with these requests. Although 14% have a policy precluding the release of blocks for research, 84% of those will send limited tissue samples in lieu of blocks. When tumor is confined to a single block, most laboratories will not release the block but will send unstained slides. Very few laboratories require reimbursement before releasing tissues. Conclusions.—Pathologists attempt to comply with requests for materials but usually refuse to release the only diagnostic paraffin block so that materials are retained for possible future needs. Other problems identified in this survey include difficulties in getting blocks returned when needed and poor communication between researchers and laboratories. Lack of reimbursement and inadequate consent are not significant barriers to release of materials.

scholarly journals Placebo Effect

2000 ◽  
Vol 1 ◽  
pp. 12-12
Keyword(s):  
Clinical Trials ◽  
Medical Association ◽  
Placebo Effect ◽  
World Medical Association ◽  
Tissue Samples

Nature and Science ran completely different news line-ups this week. But their lead stories agreed on one thing: patients matter. Nature led with a story about a group of patients who will share in a patent after giving blood and tissue samples to scientists. Science chose to lead with the controversial World Medical Association decision to recommend restricting the use of placebos in certain clinical trials.

scholarly journals ReCAP: Impact of the National Cancer Institute Community Cancer Centers Program on Clinical Trial and Related Activities at a Community Cancer Center in Rural Nebraska

2016 ◽  
Vol 12 (1) ◽  
pp. 67-68 ◽  
Author(s):  
Mehmet Sitki Copur ◽  
Ryan Ramaekers ◽  
Mithat Gönen ◽  
Mary Gulzow ◽  
Rebecca Hadenfeldt ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Cancer Care ◽  
Positive Impact ◽  
Tissue Samples ◽  
Cancer Centers ◽  
Care Services ◽  
Cancer Program ◽  
Number Of Patients ◽  
And Storage

QUESTION ASKED: What is the impact of participating in the National Cancer Institute Community Cancer Centers Program (NCCCP) on the number of clinical trials available, number of patients enrolled in trials, and trial-related services provided to patients at a rural community-based cancer program? SUMMARY ANSWER: Significant increases in the number and percentage of patients enrolled in clinical trials, in the number of available treatment and non-treatment (eg, prevention, biospecimen, cancer control) trials, in clinical trial staffing, and in the number of tissue samples collected and/or stored were observed during the 5-year period of NCCCP. Biospecimen trials helped promote standardization of collection and storage processes in our community cancer program. Employment and utilization of a genetic counselor, smoking cessation counselor, outreach project coordinator, and two nurse navigators enabled delivery of improved cancer care continuum services to our rural patient population. METHODS: SFCTC clinical trial activities data from July 2002 to June 2007, the 5 years before participation in the NCCCP, and from July 2007 to June 2012, the 5 years during the program, were gathered and compared. Data capture included information on the number and percentage of patients on clinical trials, number and type of available clinical trials, percentage of underserved patients in clinical trials, clinical trial staffing, collection and storage of tissue samples, organizational infrastructure, linkage to NCI-designated cancer centers, and availability of new cancer care services. Percentages of patients in clinical trials were calculated as the ratio of the number of patients enrolled onto clinical trials over the number of analytic new patient cases of cancer through our tumor registry per year. Percentages of tissue samples collected and/or stored were similarly measured as the number of biospecimens collected over the number of analytic new patient cases of cancer per year. Statistical analyses were performed using chi-square and Wilcoxon tests. BIAS, CONFOUNDING FACTOR(S), DRAWBACKS: Data 5 years prior to and 5 years during NCCCP were prospectively collected. Analysis of data was performed after the completion of NCCCP. REAL-LIFE IMPLICATIONS: Improving access of all adult cancer patients to clinical trials in the communities where they live is crucial to provide the best cancer care. Participation in the NCCCP had a positive impact on our clinical trial and related activities, providing our rural Nebraska population with enhanced access to both clinical trials and cancer care services. Implementing programs and policies that facilitate the delivery of high-quality care in the community setting is feasible and greatly needed. The NCCCP had a positive impact by providing expanded spectrum of clinical trial types and programs to the population of patients in our cancer program service area. [Table: see text]

Localization of Gallium-67 in Peritoneal Cells by Electron Microscopic Autoradiography

1973 ◽  
Vol 31 ◽  
pp. 404-405
Author(s):  
D. C. Swartzendruber ◽  
Norma L. Idoyaga-Vargas
Keyword(s):  
Clinical Trials ◽  
Soft Tissue ◽  
Tumor Tissue ◽  
Soft Tissue Tumors ◽  
Clinical Usefulness ◽  
Electron Microscopic ◽  
Normal Cells ◽  
Electron Microscopic Autoradiography ◽  
Peritoneal Cells ◽  
Gallium 67

The radionuclide gallium-67 (67Ga) localizes preferentially but not specifically in many human and experimental soft-tissue tumors. Because of this localization, 67Ga is used in clinical trials to detect humar. cancers by external scintiscanning methods. However, the fact that 67Ga does not localize specifically in tumors requires for its eventual clinical usefulness a fuller understanding of the mechanisms that control its deposition in both malignant and normal cells. We have previously reported that 67Ga localizes in lysosomal-like bodies, notably, although not exclusively, in macrophages of the spocytaneous AKR thymoma. Further studies on the uptake of 67Ga by macrophages are needed to determine whether there are factors related to malignancy that might alter the localization of 67Ga in these cells and thus provide clues to discovering the mechanism of 67Ga localization in tumor tissue.

In situ microprobe quantitation of inorganic particle burden in paraffin sections of lung tissue

1988 ◽  
Vol 46 ◽  
pp. 990-991
Author(s):  
Jerrold L. Abraham
Keyword(s):  
Lung Tissue ◽  
Quantitative Information ◽  
Particulate Material ◽  
Paraffin Sections ◽  
Tissue Samples ◽  
Qualitative And Quantitative ◽  
The Past ◽  
Quantitative Analyses ◽  
Data Result

Inorganic particulate material of diverse types is present in the ambient and occupational environment, and exposure to such materials is a well recognized cause of some lung disease. To investigate the interaction of inhaled inorganic particulates with the lung it is necessary to obtain quantitative information on the particulate burden of lung tissue in a wide variety of situations. The vast majority of diagnostic and experimental tissue samples (biopsies and autopsies) are fixed with formaldehyde solutions, dehydrated with organic solvents and embedded in paraffin wax. Over the past 16 years, I have attempted to obtain maximal analytical use of such tissue with minimal preparative steps. Unique diagnostic and research data result from both qualitative and quantitative analyses of sections. Most of the data has been related to inhaled inorganic particulates in lungs, but the basic methods are applicable to any tissues. The preparations are primarily designed for SEM use, but they are stable for storage and transport to other laboratories and several other instruments (e.g., for SIMS techniques).

Sign in / Sign up

Export Citation Format

Share Document