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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Gastrointestinal Stromal Tumor (GIST)
- Sponsor
- Fondazione del Piemonte per l'Oncologia
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Correlation of change in cf-DNA levels with disease status in GIST patients harboring specific DNA mutations
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Impossibility to ensure adequate clinical and serum sample follow-up
- •Serious psychiatric disease that precludes informed consent or limits compliance
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Detection of secondary mutations in KIT, PDGFRα and/or other genes(baseline, every 12 weeks, up to 2 years)
- Correlation of detection of secondary mutations in KIT, PDGFRα and/or other genes with radiological disease progression(baseline, every 12 weeks, up to 2 years)
- Correlation of the level of cf-DNA related to disease status in GIST patients harboring specific DNA mutations(baseline, every 12 weeks, up to 2 years)
- Clearance of cf-DNA levels after surgery in GIST patients harboring specific DNA mutations(the day before surgery, every 12 weeks, up to 2 years)
- Correlation of cf-DNA levels with overall survival (OS)(baseline and up to 2 years)