Validation of mutation analysis in circulating tumor DNA with a ddPCR assay as diagnostic and follow-up tool for patients with a KIT exon 11 mutated GIST: GALLOP-11

Validation of mutation analysis in circulating tumor DNA with a ddPCR assay as diagnostic and follow-up tool for patients with a KIT exon 11 mutated GIST: GALLOP-11 - GALLOP-11

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON52793

Enrollment

250

Registered

2021-02-17

Start date

2021-05-10

Completion date

Unknown

Last updated

2024-08-19

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

Conditions

gastro-intestinal stromal tumors

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Patients with GIST with a by biopsy confirmed primary KIT exon 11 mutation covered by our KIT exon 11 ddPCR assay (mutation/deletion within target sequence of c.1665 to c.1736); 2. Patients with an indication for at least 4 CT-scans (and/or MRI scans) concomitant with regular laboratory examination in a neoadjuvant, adjuvant and/or palliative care trajectory within the time frame of the study; 3. Age >=18 years; 4. Written informed consent provided.

Exclusion criteria

Exclusion criteria: 1. Patients who are unable to comply with study procedures and follow up.

Design outcomes

Primary

Measure	Time frame
The NPV of the previously developed KIT exon 11 ddPCR assay in relation to response assessment by CT-scan (and/or MRI scan). The study is considered positive once the NPV is higher than 90%.	—

Secondary

Measure	Time frame
n.a.	—

Countries

Netherlands

Outcome results