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

NCT02443948 | Unknown DMC

• 1 other identifier: cf-DNA GIST
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Stromal Tumor (GIST)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

• Detection of secondary mutations in KIT, PDGFRα and/or other genes

  baseline, every 12 weeks, up to 2 years

• Correlation of cf-DNA levels with overall survival (OS)

  baseline and 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

Study Arms (3)

adjuvant/follow up setting

Other: Vena puncture for blood collection

neo-adjuvant setting

Other: Vena puncture for blood collection

advanced disease

Other: Vena puncture for blood collection

Interventions

Vena puncture for blood collection OTHER

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

adjuvant/follow up setting; advanced disease; neo-adjuvant setting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione del Piemonte per l'Oncologia: lead

Study Sites (1)

Fondazione del Piemonte per l'Oncologia

Candiolo, TO, 10060, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2015
• First Posted: May 14, 2015
• Study Start: June 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: June 1, 2018
• Last Updated: February 14, 2017

Record last verified: 2017-02

Locations

IT (1)