CancerOncoSang-TST79NCT07868640
Blood Samples Were Taken From Patients Undergoing Oncological Treatment in Order to Validate the TST79 Molecular Test
A study testing Gene-alteration pair (G-A) in people with Cancer, run by Grand Hôpital de Charleroi at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Gene-alteration pair (G-A)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Sep 2026to 30 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- GIST/gastrointestinal stromal tumour
- melanoma
- urothelial carcinoma
- endometrial carcinoma
- high-grade ovarian carcinoma
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Grand Hôpital de Charleroi
Charleroi, Hainaut, 6060
David Schröder, MD, PhD, 0032 60 ext. 110089, david.schroder@ghdc.be
Aline Gillain, MedSC, 0032 60 ext. 110089, aline.gillain@ghdc.be
About this study
Official title: Blood Samples Were Taken From Patients Undergoing Oncological Treatment in Order to Validate the TST79 Molecular Test at the Department of Pathology at the Grand Hôpital de Charleroi.
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.
Read the detailed description
The development of targeted therapies in oncology requires the regular implementation of new tests. Routine clinical analyses currently focus mainly on tumour tissue, but analyses of blood components - particularly plasma - or other biological fluids from patients with cancer are gaining clinical significance in light of advances in molecular biology techniques and knowledge in oncology.
The laboratory wishes to offer patients with cancer sequencing of circulating free DNA (ctDNA) in plasma using a commercial test developed by Illumina. This test can detect various types of mutations (point mutations, small deletions or insertions, loss or gain of gene copy number, and gene fusions) in 79 genes (TST79 test).
- Conditions
- Cancer
- Being tested
- Gene-alteration pair (G-A)
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gene-alteration pair (G-A)Genetic
Point mutations, small insertions or deletions (indels), gene fusions, copy number amplifications.
| Study group | Role | What they receive |
|---|---|---|
| 2 patients with POLE-mutated endometrial cancer | Experimental | Not described Receives: Genetic: Gene-alteration pair (G-A) |
| 2-4 patients with lung adenocarcinoma involving rare gene fusions | Experimental | Not described Receives: Genetic: Gene-alteration pair (G-A) |
| 1-2 patients with lung adenocarcinoma with a point mutation in EGFR | Experimental | Not described Receives: Genetic: Gene-alteration pair (G-A) |
| 2-3 patients with GIST (gastrointestinal stromal tumour) harbouring a KIT mutation | Experimental | Not described Receives: Genetic: Gene-alteration pair (G-A) |
| 2-3 patients with clear-cell renal cell carcinoma with a VHL mutation | Experimental | Not described Receives: Genetic: Gene-alteration pair (G-A) |
| 1-2 patients with breast cancer with ERBB2 amplification | Experimental | Not described Receives: Genetic: Gene-alteration pair (G-A) |
| 2-3 patients with high-grade ovarian carcinoma and a BRCA1 or BRCA2 mutation | Experimental | Not described Receives: Genetic: Gene-alteration pair (G-A) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start15 Sep 2026
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be included based on the criteria relating to their mutations, which can be validated by the TST79 test.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grand Hôpital de Charleroi
- Sponsor type
- University, hospital or other
- Collaborators
- Institut de Pathologie et de Génétique Charleroi
- Responsible party
- Sponsor
- Investigators
- David Schröder, MD, PhD, Principal investigator, Grand Hôpital de Charleroi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07868640
- Sponsor's protocol ID
- OncoSangTST79
- Acronym
- OncoSang-TST79
- Status last verified
- Oct 2026
- First submitted
- 24 Sep 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Samples Were Taken From Patients Undergoing Oncological Treatment in Order to Validate the TST79 Molecular Test at the Department of Pathology at the Grand Hôpital de Charleroi.
- ClinicalTrials.gov ID
- NCT07868640
- Acronym / sponsor ID
- OncoSang-TST79 / OncoSangTST79
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Grand Hôpital de CharleroiUniversity, hospital or other
- Collaborators
- Institut de Pathologie et de Génétique Charleroi
- Study start
- 15 Sep 2026 (actual)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 9 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The development of targeted therapies in oncology requires the regular implementation of new tests. Routine clinical analyses currently focus mainly on tumour tissue, but analyses of blood components - particularly plasma - or other biological fluids from patients with cancer are gaining clinical significance in light of advances in molecular biology techniques and knowledge in oncology.
The laboratory wishes to offer patients with cancer sequencing of circulating free DNA (ctDNA) in plasma using a commercial test developed by Illumina. This test can detect various types of mutations (point mutations, small deletions or insertions, loss or gain of gene copy number, and gene fusions) in 79 genes (TST79 test).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
- Model description
- Patients will be included based on the criteria relating to their mutations, which can be validated by the TST79 test.
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gene-alteration pair (G-A)Point mutations, small insertions or deletions (indels), gene fusions, copy number amplifications. | Genetic | 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 |
Primary outcome
To validate and accredit the TST79 test on plasma samples within the hospital's pathology laboratory
Time frame: Through study completion, an average of two years
The aim is to extend tumour DNA sequencing to circulating tumour DNA (ctDNA), which is present in the plasma of cancer patients.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Schröder, MD, PhD principal investigator
Grand Hôpital de Charleroi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gene-alteration pair (G-A) in people with Cancer, run by Grand Hôpital de Charleroi at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Schröder, MD, PhD (0032 60 ext. 110089, david.schroder@ghdc.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To validate and accredit the TST79 test on plasma samples within the hospital's pathology laboratory (time frame: Through study completion, an average of two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.