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

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ClinicalTrials.gov Identifier: NCT02443948
Recruitment Status : Unknown
Verified February 2017 by Fondazione del Piemonte per l'Oncologia.
Recruitment status was:  Recruiting
First Posted : May 14, 2015
Last Update Posted : February 14, 2017
Sponsor:
Information provided by (Responsible Party):
Fondazione del Piemonte per l'Oncologia

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.

Condition or disease Intervention/treatment
Gastrointestinal Stromal Tumor (GIST) Other: Vena puncture for blood collection

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.


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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : June 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : June 2018


Group/Cohort Intervention/treatment
adjuvant/follow up setting Other: Vena puncture for blood collection
Cf-DNA blood samples will be collected in EDTA tubes (20 ml) during the routine blood test

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

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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Clearance of cf-DNA levels after surgery in GIST patients harboring specific DNA mutations [ Time Frame: the day before surgery, every 12 weeks, up to 2 years ]
    To evaluate the time (half-life esteem) of cf-DNA levels clearance after definitive surgery

  2. Detection of secondary mutations in KIT, PDGFRα and/or other genes [ Time Frame: baseline, every 12 weeks, up to 2 years ]
    To evaluate the possibility to detect secondary mutations in KIT, PDGFRα and/or other genes

  3. Correlation of cf-DNA levels with overall survival (OS) [ Time Frame: baseline and up to 2 years ]
    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)

  4. Correlation of detection of secondary mutations in KIT, PDGFRα and/or other genes with radiological disease progression [ Time Frame: baseline, every 12 weeks, up to 2 years ]
    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

  5. Correlation of the level of cf-DNA related to disease status in GIST patients harboring specific DNA mutations [ Time Frame: baseline, every 12 weeks, up to 2 years ]
    To assess if the cf-DNA levels are related to disease status detected according to Choi criteria.


Biospecimen Retention:   Samples With DNA
Cf-DNA blood samples will be collected in EDTA tubes during the routine blood test.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02443948


Locations
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Italy
Fondazione del Piemonte per l'Oncologia Recruiting
Candiolo, TO, Italy, 10060
Contact: Giovanni Grignani, MD    +39011993 ext 3623    giovanni.grignani@ircc.it   
Contact: Alberto Bardelli, Prof.    +39.011.993 ext 3235    alberto.bardelli@ircc.it   
Sub-Investigator: Sandra Aliberti, MD         
Sub-Investigator: Erica Palesandro, MD         
Sub-Investigator: Lorenzo D'Ambrosio, MD         
Sub-Investigator: Paola Boccone, MD         
Sub-Investigator: Danilo Galizia, MD         
Sub-Investigator: Sara Miano, MD         
Sponsors and Collaborators
Fondazione del Piemonte per l'Oncologia

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Responsible Party: Fondazione del Piemonte per l'Oncologia
ClinicalTrials.gov Identifier: NCT02443948     History of Changes
Other Study ID Numbers: cf-DNA GIST
First Posted: May 14, 2015    Key Record Dates
Last Update Posted: February 14, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
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Gastrointestinal Stromal Tumors
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases