Detection of CF-DNA in Patients With Gastrointestinal Stromal Tumors (GIST)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2016-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Activating mutations of the kinases CKIT or PDGFRA can be detected in 90% of cases by DNA sequence analysis of a pathological specimen. These mutated genomic DNA fragments are highly specific for the tumor and are released by the tumor into the circulation. Allele-specific PCR can be used to specifically amplify and quantify mutated CKIT and PDGFR DNA fragments.

The current trial aims to evaluate whether tumor DNA carrying mutations for CKIT and PDGFRA can be detected and quantified in the plasma of patients with active GIST, and whether detection can be correlated with the clinical course of disease either under therapy or in progressive disease irrespective of current therapy.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT02443948

Gastrointestinal Stromal Tumor (GIST)

UNKNOWN

GIST: Assessment of Tumor Mutations and TKI Plasma Exposure

NCT02331914

Gastro-intestinal Stromal Tumor

COMPLETED

Clinical Evaluation of Genetron D842V PCR Kit in GIST Patients

NCT05400018

GIST Gastrointestinal Stromal Tumors

COMPLETED

Prediction of Postoperative Treatment Efficacy and Recurrence Risk of High-risk GIST Based on Liquid Biopsy MRD

NCT05408897

Gastrointestinal Stromal Tumors Minimal Residual Disease

RECRUITING

Oncogenetic Panel and Integrated Clinical Data Registry Study for Wild Type Gastrointestinal Stromal Tumor Patients

NCT04821895

Gastrointestinal Stromal Tumor (GIST)

ACTIVE_NOT_RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gastrointestinal Stromal Tumors

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Single arm

Group Type NO_INTERVENTION

Blood will be withdrawn at baseline and in intervals of 3 months for a total period of 2 years

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Blood will be withdrawn at baseline and in intervals of 3 months for a total period of 2 years

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Signed written informed consent
* Male or female patients aged \>= 18 years
* Histologically confirmed GIST
* Known activating mutation of CKIT or PDGFRA and tissue sample can be provided for central mutation analysis or mutation status unknown and tissue sample can be provided for central mutation analysis at baseline
* Routinely planned follow-up visits in no longer than three months intervals (+ 14 days) including local standard of care diagnostic imaging (CT, PET- CT, or MRI)
* At least one GIST lesion that can be measured by CT, PET-CT, or MRI
* Planned surgery of one or more disease manifestations or planned TKI treatment (such as imatinib or sunitinib) in neoadjuvant or palliative intention or disease progression irrespective of current/planned treatment
* Life expectancy of at least three months

Exclusion Criteria

* Wild type sequence for CKIT exon 9, 11, 13, 14, 17, 18 and PDGFRA exon 18
* Tissue sample can not be provided for central mutation analysis
* Surgery of primary or progressive lesions already completed and currently no evidence of progressive lesions
* Patients currently receiving adjuvant TKI treatment after surgery and no evidence of progressive lesions
* Patients currently receiving palliative TKI treatment and no evidence of progressive lesions
* Planned follow-up intervals including CT, PET-CT or MRI at more than three months intervals (+ 14 days)
* Coexisting medical condition or treatment that could interfere with the ability of the patient to comply with planned treatment interventions (surgery or TKI treatment) or regular follow-up visits
* Patients unwilling to or unable to comply with the planned therapeutic intervention (surgery or TKI treatment) or to comply with the regular follow-up visits including blood sample collection
* Pregnancy and lactation
* Presence of chronic inflammatory diseases, autoimmune diseases, or liver cirrhosis
* Known HIV and/or hepatitis B or C infection
* Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix and basal or squamous cell carcinoma of the skin

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No