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

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 - CF DNA GIST

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-002544-27-DE

Enrollment

Unknown

Registered

2011-09-06

Start date

2011-10-18

Completion date

Unknown

Last updated

2016-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with gastrointestinal stromal tumor (GIST) harboring activating mutations of CKIT or PDGFRA pre/post surgery or pre/under treatment with a Tyrokinase Inhibitors or progressive disease irrespective of current or planned treatment.

Interventions

Pharmaceutical Form: INN or Proposed INN: SUNITINIB CAS Number: 557795-19-4 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Pharmaceutical Form: INN or Propo

Eligibility

Sex/Gender

All

Inclusion criteria

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 ir-respective of current/planned treatment • Life expectancy of at least three months Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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 sur-gery 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 sam-ple collection • Pregnancy and lactation • Presence of chronic inflammatory diseases, autoimmune dis-eases, or liver cirrhosis • Known HIV and/or hepatitis B or C infection • Other malignancies within the past 3 years except for ade-quately treated carcinoma of the cervix and basal or squamous cell carcinoma of the skin

Design outcomes

Primary

Measure	Time frame
Main Objective: Goal of the study is to investigate whether tumor-specific CKIT or PDGFRA DNA fragments can be detected and quantified in the plasma of patients with active GIST as defined as GIST lesions that can be measured by diagnostic imaging.;Secondary Objective: The secondary objectives are: • To assess the correlation of test results with the amount of tumor • To investigate whether the test result correlates with response to therapy • To investigate whether the test result correlates with relapse or progression of disease • To determine whether medical treatment results in a transient increase of CKIT or PDGFA DNA in the plasma • To determine the test sensitivity of L-PCR, ddPCR and NGS for specific CKIT or PGDFRA mutations • To determine whether tumor clonal heterogeneity can be de-tected in plasma DNA using L-PCR, NGS or ddPCR • To examine whether clonal heterogeneity of tumor specific mutations in plasma samples correlates with response, re-lapse and progression ;Primary end point(s): 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;Timepoint(s) of evaluation of this end point: Detection of tumor specific DNA encoding for mutated CKIT or PDGFA in the plasma at least at one timepoint	—

Measure

Time frame

Main Objective: Goal of the study is to investigate whether tumor-specific CKIT or PDGFRA DNA fragments can be detected and quantified in the plasma of patients with active GIST as defined as GIST lesions that can be measured by diagnostic imaging.;Secondary Objective: The secondary objectives are: • To assess the correlation of test results with the amount of tumor • To investigate whether the test result correlates with response to therapy • To investigate whether the test result correlates with relapse or progression of disease • To determine whether medical treatment results in a transient increase of CKIT or PDGFA DNA in the plasma • To determine the test sensitivity of L-PCR, ddPCR and NGS for specific CKIT or PGDFRA mutations • To determine whether tumor clonal heterogeneity can be de-tected in plasma DNA using L-PCR, NGS or ddPCR • To examine whether clonal heterogeneity of tumor specific mutations in plasma samples correlates with response, re-lapse and progression ;Primary end point(s): 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;Timepoint(s) of evaluation of this end point: Detection of tumor specific DNA encoding for mutated CKIT or PDGFA in the plasma at least at one timepoint

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Secondary

Measure	Time frame
Secondary end point(s): • Correlation between the amount of tumor specific CKIT or PDGFRA DNA in plasma samples and the amount of tumor as assessed by diagnostic imaging • Correlation between the amount of tumor specific CKIT or PDGFRA DNA in plasma samples and the response to ther-apy (surgery and/or therapy with a TKI) as assessed by di-agnostic imaging • Correlation between the amount of tumor specific CKIT or PDGFRA DNA in plasma samples and relapse or progression of disease as assessed by diagnostic imaging • Percentage of patients with transient increase of tumor spe-cific CKIT or PDGFRA DNA in the plasma („tumor flare“) af-ter starting a medical treatment with a TKI • Comparison of the sensitivity of L-PCR, ddPCR and NGS for specific CKIT or PGDFRA mutations • Percentage of patients with more than one GIST-specific mu-tation in plasma DNA • Correlation between detection of more than one GIST-specific mutation in plasma DNA and the response to therapy (surgery and/or therapy with a TKI) as assessed by diagnostic imaging • Correlation between detection of more than one GIST-specific mutation in plasma samples and relapse or progres-sion of disease as assessed by diagnostic imaging ;Timepoint(s) of evaluation of this end point: Patients with GIST receiving standard medical care according to hospital routine will be included. For the purpose of this clinical trial blood samples will be taken at baseline and during the patient's regular follow-up visits in the clinic in 3-months intervals in order to detect circulating tumor DNA in the plasma. The amount of circulating mutated CKIT or PDGFRA DNA will be correlated with the clinical course of disease as assessed by imaging, which will be performed according to the clinical centre's routine follow-up of the patient.	—

Measure

Time frame

Secondary end point(s): • Correlation between the amount of tumor specific CKIT or PDGFRA DNA in plasma samples and the amount of tumor as assessed by diagnostic imaging • Correlation between the amount of tumor specific CKIT or PDGFRA DNA in plasma samples and the response to ther-apy (surgery and/or therapy with a TKI) as assessed by di-agnostic imaging • Correlation between the amount of tumor specific CKIT or PDGFRA DNA in plasma samples and relapse or progression of disease as assessed by diagnostic imaging • Percentage of patients with transient increase of tumor spe-cific CKIT or PDGFRA DNA in the plasma („tumor flare“) af-ter starting a medical treatment with a TKI • Comparison of the sensitivity of L-PCR, ddPCR and NGS for specific CKIT or PGDFRA mutations • Percentage of patients with more than one GIST-specific mu-tation in plasma DNA • Correlation between detection of more than one GIST-specific mutation in plasma DNA and the response to therapy (surgery and/or therapy with a TKI) as assessed by diagnostic imaging • Correlation between detection of more than one GIST-specific mutation in plasma samples and relapse or progres-sion of disease as assessed by diagnostic imaging ;Timepoint(s) of evaluation of this end point: Patients with GIST receiving standard medical care according to hospital routine will be included. For the purpose of this clinical trial blood samples will be taken at baseline and during the patient's regular follow-up visits in the clinic in 3-months intervals in order to detect circulating tumor DNA in the plasma. The amount of circulating mutated CKIT or PDGFRA DNA will be correlated with the clinical course of disease as assessed by imaging, which will be performed according to the clinical centre's routine follow-up of the patient.

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Countries

Germany

Contacts

Public ContactViktoria Janke

Muenchner Studienzentrum

viktoria.janke@mri.tum.de+4908941407717

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026