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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Klinikum rechts der Isar - III. Medizinische Klinik und Poliklinik

Munich, Bavaria, 81675, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood will be withdrawn at baseline and in intervals of 3 months for a total period of 2 years

Other

Primary outcomes

Percentage of patients with histologically proven GIST, measurable lesion in imaging and activating CKIT and PDGFRA mutation, where detection of tumor specific DNA encoding for mutated CKIT or PDGFA is possible in the plasma at least at one timepoint

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Registry information

Official study title

Prospective, Explorative Trial for the Detection of Circulating Cell-free Tumor DNA in the Plasma of Patients With Gastrointestinal Stromal Tumors (GIST)Harboring Activating Mutations of CKIT or PDGFRA Pre/Post Surgery or Pre/Under Treatment With a Tyrosine Kinase Inhibitor or Progressive Disease Irrespective of Current or Planned Treatment. An Open-label, Non-randomized, Multicenter Phase IIIb Clinical Trial

Important dates

Study start: 2011
Primary completion: 2015
Study completion: 2016
First posted: Nov 1, 2011
Registry last updated: Mar 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed