Circulating Cell-free Tumor DNA in the Plasma of Patients With Gastrointestinal Stromal Tumors (GIST)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-30

Study Completion Date

2018-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Gastrointestinal Stromal Tumor (GIST)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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adjuvant/follow up setting

Vena puncture for blood collection

Intervention Type OTHER

Cf-DNA blood samples will be collected in EDTA tubes (20 ml) during the routine blood test

neo-adjuvant setting

Vena puncture for blood collection

Intervention Type OTHER

Cf-DNA blood samples will be collected in EDTA tubes (20 ml) during the routine blood test

advanced disease

Vena puncture for blood collection

Intervention Type OTHER

Cf-DNA blood samples will be collected in EDTA tubes (20 ml) during the routine blood test

Interventions

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Vena puncture for blood collection

Cf-DNA blood samples will be collected in EDTA tubes (20 ml) during the routine blood test

Intervention Type OTHER

Eligibility Criteria

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Exclusion Criteria

* Impossibility to ensure adequate clinical and serum sample follow-up
* Serious psychiatric disease that precludes informed consent or limits compliance

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No