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

Gastrointestinal Stromal Tumor (GIST) Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02443948
• Other study ID #: cf-DNA GIST
• Status: Recruiting
• Phase: N/A
• First received: March 19, 2015
• Last updated: February 13, 2017
• Start date: June 2014
• Est. completion date: June 2018

Study information

• Verified date: February 2017
• Source: Fondazione del Piemonte per l'Oncologia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

• Male or female patients aged >= 18 years

• Histologically confirmed diagnosis of GIST of any anatomical location either by biopsy or surgical specimen

• Available archival tumor tissue

• Signed informed consent form

Exclusion Criteria:

• Impossibility to ensure adequate clinical and serum sample follow-up

• Serious psychiatric disease that precludes informed consent or limits compliance

Related Conditions & MeSH terms

• Gastrointestinal Stromal Tumor (GIST)
• Gastrointestinal Stromal Tumors

Intervention

Other:
• Vena puncture for blood collection
Cf-DNA blood samples will be collected in EDTA tubes (20 ml) during the routine blood test

Locations

Country	Name	City	State
Italy	Fondazione del Piemonte per l'Oncologia	Candiolo	TO

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione del Piemonte per l'Oncologia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of change in cf-DNA levels with disease status in GIST patients harboring specific DNA mutations	To assess the correlation of change in cf-DNA levels with disease status evaluated according to RECIST criteria v 1.1	baseline, every 12 weeks, up to 2 years
Secondary	Clearance of cf-DNA levels after surgery in GIST patients harboring specific DNA mutations	To evaluate the time (half-life esteem) of cf-DNA levels clearance after definitive surgery	the day before surgery, every 12 weeks, up to 2 years
Secondary	Detection of secondary mutations in KIT, PDGFRa and/or other genes	To evaluate the possibility to detect secondary mutations in KIT, PDGFRa and/or other genes	baseline, every 12 weeks, up to 2 years
Secondary	Correlation of cf-DNA levels with overall survival (OS)	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)	baseline and up to 2 years
Secondary	Correlation of detection of secondary mutations in KIT, PDGFRa and/or other genes with radiological disease progression	To correlate the detection of secondary mutations in KIT, PDGFRa and/or other genes with radiological disease progression according to RECIST criteria v 1.1	baseline, every 12 weeks, up to 2 years
Secondary	Correlation of the level of cf-DNA related to disease status in GIST patients harboring specific DNA mutations	To assess if the cf-DNA levels are related to disease status detected according to Choi criteria.	baseline, every 12 weeks, up to 2 years