Circulating Cell-free Tumor DNA in the Plasma of Patients With Gastrointestinal Stromal Tumors (GIST)
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ClinicalTrials.gov Identifier: NCT02443948 |
Recruitment Status : Unknown
Verified February 2017 by Fondazione del Piemonte per l'Oncologia.
Recruitment status was: Recruiting
First Posted : May 14, 2015
Last Update Posted : February 14, 2017
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Tracking Information | |||
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First Submitted Date | March 19, 2015 | ||
First Posted Date | May 14, 2015 | ||
Last Update Posted Date | February 14, 2017 | ||
Study Start Date | June 2014 | ||
Estimated Primary Completion Date | December 2017 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures |
Correlation of change in cf-DNA levels with disease status in GIST patients harboring specific DNA mutations [ Time Frame: baseline, every 12 weeks, up to 2 years ] To assess the correlation of change in cf-DNA levels with disease status evaluated according to RECIST criteria v 1.1
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Original Primary Outcome Measures | Same as current | ||
Change History | |||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||
Current Other Pre-specified Outcome Measures | Not Provided | ||
Original Other Pre-specified Outcome Measures | Not Provided | ||
Descriptive Information | |||
Brief Title | Circulating Cell-free Tumor DNA in the Plasma of Patients With Gastrointestinal Stromal Tumors (GIST) | ||
Official Title | Circulating Cell-free Tumor DNA in the Plasma of Patients With Gastrointestinal Stromal Tumors (GIST): Detection and Correlation With Disease Status Assessed by Conventional Technique. Prospective Observational Study | ||
Brief Summary | This observational study is proposed to evaluate if the trend in the levels of cf-DNA evaluated on a sample of peripheral blood may be related to different clinical behaviors of the disease monitored by radiological investigations conducted. | ||
Detailed Description | Demetri and colleagues presented, at the AACR and ASCO Annual Meeting 2013, an exploratory analysis to assess GIST genotypes on patients in the GRID study. Mutations in the KIT gene were detected in 58 percent of the blood samples compared with 66 percent of the tumor tissue samples (31). However, when focusing their analysis on secondary KIT mutations, which are the mutations that drive resistance to targeted therapies like imatinib and sunitinib, the researchers found mutations in 47 percent of blood samples compared with only 12 percent of tissue samples. In addition, nearly half of blood samples in which secondary KIT mutations were found, harbored multiple secondary mutations. Therefore, cf-DNA may become an efficient marker of mutational GIST status and disease itself. On this basis, this trial aims to evaluate whether tumor DNA carrying mutations (for KIT, PDGFRα, BRAF, RAS, SDH) can be detected and quantified in the plasma of patients with GISTs, either with active disease or during follow-up, and whether detection can be correlated with the disease status. |
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Study Type | Observational | ||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||
Biospecimen | Retention: Samples With DNA Description: Cf-DNA blood samples will be collected in EDTA tubes during the routine blood test.
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Sampling Method | Non-Probability Sample | ||
Study Population | The target population includes adult patients with histologically confirmed GIST, either with active disease or in follow-up. | ||
Condition | Gastrointestinal Stromal Tumor (GIST) | ||
Intervention | Other: Vena puncture for blood collection
Cf-DNA blood samples will be collected in EDTA tubes (20 ml) during the routine blood test
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Study Groups/Cohorts |
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Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status | Unknown status | ||
Estimated Enrollment |
60 | ||
Original Estimated Enrollment | Same as current | ||
Estimated Study Completion Date | June 2018 | ||
Estimated Primary Completion Date | December 2017 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria |
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||
Accepts Healthy Volunteers | No | ||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries | Italy | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number | NCT02443948 | ||
Other Study ID Numbers | cf-DNA GIST | ||
Has Data Monitoring Committee | Yes | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement | Not Provided | ||
Current Responsible Party | Fondazione del Piemonte per l'Oncologia | ||
Original Responsible Party | Same as current | ||
Current Study Sponsor | Fondazione del Piemonte per l'Oncologia | ||
Original Study Sponsor | Same as current | ||
Collaborators | Not Provided | ||
Investigators | Not Provided | ||
PRS Account | Fondazione del Piemonte per l'Oncologia | ||
Verification Date | February 2017 |