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

Vena puncture for blood collection

Giovanni Grignani, MD

Alberto Bardelli, Prof.

Sandra Aliberti, MD

Erica Palesandro, MD

Lorenzo D'Ambrosio, MD

Paola Boccone, MD

Danilo Galizia, MD

Sara Miano, MD

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.

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.

Cf-DNA blood samples will be collected in EDTA tubes during the routine blood test.

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

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

To assess the correlation of change in cf-DNA levels with disease status evaluated according to RECIST criteria v 1.1

To evaluate the time (half-life esteem) of cf-DNA levels clearance after definitive surgery

To evaluate the possibility to detect secondary mutations in KIT, PDGFRα and/or other genes

To evaluate the correlation between cf-DNA levels and overall survival (time from the date of enrollment to date of death or to the date being censored at two years, whichever occurs first)

To correlate the detection of secondary mutations in KIT, PDGFRα and/or other genes with radiological disease progression according to RECIST criteria v 1.1

To assess if the cf-DNA levels are related to disease status detected according to Choi criteria.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Circulating Cell-free Tumor DNA in the Plasma of Patients With Gastrointestinal Stromal Tumors (GIST)	NCT02443948	Gastrointestina...	Vena puncture f...	18 Years -	Fondazione del Piemonte per l'Oncologia
Circulating Cell-free Tumor DNA in the Plasma of Patients With Gastrointestinal Stromal Tumors (GIST)	NCT02443948	Gastrointestina...	Vena puncture f...	18 Years -	Fondazione del Piemonte per l'Oncologia

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