Gastrointestinal Stromal Tumor (GIST)NCT02443948
Circulating Cell-free Tumor DNA in the Plasma of Patients With Gastrointestinal Stromal Tumors (GIST)
An observational study of Gastrointestinal Stromal Tumor (GIST), run by Fondazione del Piemonte per l'Oncologia at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Stromal Tumor (GIST)
- What is being tested?
- Vena puncture for blood collection
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2014to Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The target population includes adult patients with histologically confirmed GIST, either with active disease or in follow-up.
Who may be able to join
None listed.
Who cannot join
- Impossibility to ensure adequate clinical and serum sample follow-up
- Serious psychiatric disease that precludes informed consent or limits compliance
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione del Piemonte per l'Oncologia
Candiolo, TO, 10060
Giovanni Grignani, MD, +39011993 ext. 3623, giovanni.grignani@ircc.it
Alberto Bardelli, Prof., +39.011.993 ext. 3235, alberto.bardelli@ircc.it
About this study
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
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.
Read the 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.
- Conditions
- Gastrointestinal Stromal Tumor (GIST)
- Being tested
- Vena puncture for blood collection
- Medical subject headings
- Gastrointestinal Stromal Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vena puncture for blood collectionOther
Cf-DNA blood samples will be collected in EDTA tubes (20 ml) during the routine blood test
| Study group | Role | What they receive |
|---|---|---|
| adjuvant/follow up setting | Not described Receives: Other: Vena puncture for blood collection | |
| neo-adjuvant setting | Not described Receives: Other: Vena puncture for blood collection | |
| advanced disease | Not described Receives: Other: Vena puncture for blood collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
To evaluate the time (half-life esteem) of cf-DNA levels clearance after definitive surgery
Measured: the day before surgery, every 12 weeks, up to 2 years
Detection of secondary mutations in KIT, PDGFRα and/or other genes
To evaluate the possibility to detect secondary mutations in KIT, PDGFRα and/or other genes
Measured: baseline, every 12 weeks, up to 2 years
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)
Measured: baseline and up to 2 years
Correlation of detection of secondary mutations in KIT, PDGFRα and/or other genes with radiological disease progression
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
Measured: 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
To assess if the cf-DNA levels are related to disease status detected according to Choi criteria.
Measured: baseline, every 12 weeks, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2015 (estimated)
- Study startJun 2014
- Primary completionDec 2017 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal Stromal Tumor (GIST)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione del Piemonte per l'Oncologia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02443948
- Sponsor's protocol ID
- cf-DNA GIST
- Status last verified
- Feb 2017
- First submitted
- 19 Mar 2015
- Last updated
- 14 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02443948
- Acronym / sponsor ID
- cf-DNA GIST
- Conditions
- Gastrointestinal Stromal Tumor (GIST)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fondazione del Piemonte per l'OncologiaUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 14 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The target population includes adult patients with histologically confirmed GIST, either with active disease or in follow-up.
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Impossibility to ensure adequate clinical and serum sample follow-up
- Serious psychiatric disease that precludes informed consent or limits compliance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vena puncture for blood collectionCf-DNA blood samples will be collected in EDTA tubes (20 ml) during the routine blood test | Other | adjuvant/follow up setting, advanced disease, neo-adjuvant setting |
Primary outcome
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
5 secondary outcomes
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
Detection of secondary mutations in KIT, PDGFRα and/or other genes
Time frame: baseline, every 12 weeks, up to 2 years
Correlation of cf-DNA levels with overall survival (OS)
Time frame: baseline and up to 2 years
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Stromal Tumor (GIST), run by Fondazione del Piemonte per l'Oncologia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2017.