Blood Samples Were Taken From Patients Undergoing Oncological Treatment in Order to Validate the TST79 Molecular Test

NCT07868640 | Recruiting

• 1 other identifier: OncoSangTST79
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The pathological anatomy laboratory, which is managed by the IPG, would involve monitoring patients being treated for cancer and receiving care at the GHDC in order to take blood samples from those in whom the presence of plasma ctDNA carrying a mutation in a specific gene is suspected - a mutation detectable by the TST79 test.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• To validate and accredit the TST79 test on plasma samples within the hospital's pathology laboratory

  The aim is to extend tumour DNA sequencing to circulating tumour DNA (ctDNA), which is present in the plasma of cancer patients.

  Through study completion, an average of two years

Study Arms (7)

2 patients with POLE-mutated endometrial cancer

EXPERIMENTAL

Genetic: Gene-alteration pair (G-A)

2-4 patients with lung adenocarcinoma involving rare gene fusions

EXPERIMENTAL

Genetic: Gene-alteration pair (G-A)

1-2 patients with lung adenocarcinoma with a point mutation in EGFR

EXPERIMENTAL

Genetic: Gene-alteration pair (G-A)

2-3 patients with GIST (gastrointestinal stromal tumour) harbouring a KIT mutation

EXPERIMENTAL

Genetic: Gene-alteration pair (G-A)

2-3 patients with clear-cell renal cell carcinoma with a VHL mutation

EXPERIMENTAL

Genetic: Gene-alteration pair (G-A)

1-2 patients with breast cancer with ERBB2 amplification

EXPERIMENTAL

Genetic: Gene-alteration pair (G-A)

2-3 patients with high-grade ovarian carcinoma and a BRCA1 or BRCA2 mutation

EXPERIMENTAL

Genetic: Gene-alteration pair (G-A)

Interventions

Gene-alteration pair (G-A) GENETIC

Point mutations, small insertions or deletions (indels), gene fusions, copy number amplifications.

1-2 patients with breast cancer with ERBB2 amplification; 1-2 patients with lung adenocarcinoma with a point mutation in EGFR; 2 patients with POLE-mutated endometrial cancer; 2-3 patients with GIST (gastrointestinal stromal tumour) harbouring a KIT mutation; 2-3 patients with clear-cell renal cell carcinoma with a VHL mutation; 2-3 patients with high-grade ovarian carcinoma and a BRCA1 or BRCA2 mutation; 2-4 patients with lung adenocarcinoma involving rare gene fusions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with the following types of cancer may be invited to donate blood as part of one of two approaches:
• lung adenocarcinoma
• colorectal adenocarcinoma
• breast carcinoma
• prostate adenocarcinoma
• clear cell renal cell carcinoma
• GIST/gastrointestinal stromal tumour
• melanoma
• urothelial carcinoma
• endometrial carcinoma
• high-grade ovarian carcinoma

Sponsors & Collaborators

• Grand Hôpital de Charleroi: lead
• Institut de Pathologie et de Génétique Charleroi: collaborator

Study Sites (1)

Grand Hôpital de Charleroi

Charleroi, Hainaut, 6060, Belgium

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• David Schröder, MD, PhD

  Grand Hôpital de Charleroi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Schröder, MD, PhD

CONTACT

0032 60; david.schroder@ghdc.be

Aline Gillain, MedSciences

CONTACT

0032 60; aline.gillain@ghdc.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be included based on the criteria relating to their mutations, which can be validated by the TST79 test.

Study Record Dates

• First Submitted: September 24, 2026
• First Posted: October 9, 2026
• Study Start: September 15, 2026
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: October 9, 2026

Record last verified: 2026-10

Locations

BE (1)