Colon CancerGERSOMNCT07555639
An Integrated Genomic Approach to Assess Genetic Risk and Drug Sensitivity
A study testing Genomic profile in people with Colon Cancer and Breast Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
National multicenter prospective study, involving the enrollment of approximately 1,500 patients with ovarian cancer, 1,500 patients with breast cancer, and 1,000 patients with colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer, Breast Cancer, Ovarian Cancer
- What is being tested?
- Genomic profile
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,000 participants
- Where
- 1 siteItaly
- Study dates
- 21 Nov 2019to 31 Dec 2032
- 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
- Ovary
- Newly diagnosed patients with epithelial ovarian, peritoneal, or fallopian tube tumors of any histology and stage, excluding borderline tumors, who are scheduled to undergo an invasive diagnostic or therapeutic procedure (surgery or biopsy). In the case of neoadjuvant therapy, availability of a pre-treatment biopsy sample is required.
- Age > 18 years.
- Written informed consent.
- Patients with recurrent disease, either untreated or treated with no more than one prior line of therapy, who are scheduled to undergo an invasive diagnostic or therapeutic procedure (surgery or biopsy), provided that paraffin-embedded tissue from the untreated primary tumor is available, not older than 2 years, and that a new pre-enrollment biopsy is feasible.
- Patients in remission (identified during follow-up) who have received no more than one prior line of therapy, provided that paraffin-embedded tissue from the untreated primary tumor is available and not older than 2 years.
Show all 20Show fewer
- Breast
- Triple-negative breast cancer (ER and PgR <10% and HER2 negative: IHC 0, 1+, or 2+ with non-amplified ISH) or breast cancer diagnosed in patients younger than 40 years, who are scheduled to undergo an invasive diagnostic or therapeutic procedure (surgery or biopsy).
- Eligible patients include:
- Early-stage disease (neoadjuvant or adjuvant setting). In the case of neoadjuvant therapy, availability of a pre-treatment biopsy sample before chemotherapy is required.
- Metastatic disease. In this setting, prior chemotherapy for early-stage breast cancer (neoadjuvant and/or adjuvant) is allowed, provided that paraffin-embedded tissue from the untreated primary tumor is available, not older than 2 years, and that a new pre-enrollment biopsy is feasible.
- Patients in remission (identified during follow-up) who have received no more than one prior line of therapy (in any setting), provided that paraffin-embedded tissue from the untreated primary tumor is available and not older than 2 years.
- Age > 18 years.
- Written informed consent.
- Colorectal
- Newly diagnosed patients with colorectal cancer (including metastatic disease) who are scheduled to undergo an invasive diagnostic or therapeutic procedure (surgery or biopsy). In the case of neoadjuvant therapy, availability of a pre-treatment biopsy sample is required.
- Age > 18 and < 50 years.
- Written informed consent.
- Patients with recurrent disease, either untreated or treated with no more than one prior line of therapy, who are scheduled to undergo an invasive diagnostic or therapeutic procedure (surgery or biopsy), provided that paraffin-embedded tissue from the untreated primary tumor is available, not older than 2 years, and that a new pre-enrollment biopsy is feasible.
- Patients in remission (identified during follow-up) who have received no more than one prior line of therapy, provided that paraffin-embedded tissue from the untreated primary tumor is available and not older than 2 years.
Who cannot join
- Inability or unwillingness to undergo oncogenetic counseling;
- More than one prior line of chemotherapy (in any disease setting);
- For patients enrolled in the absence of active disease and identified during follow-up, unavailability of untreated tumor tissue obtained within the previous 2 years;
- For patients enrolled with active disease, tumor site not accessible for biopsy sampling.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Policlinico Universitario Agostino Gemelli, IRCCS
Roma, Roma, 00136
About this study
Official title: Feasibility Study for Combined Genomic Diagnosis of Genetic Risk and Drug Sensitivity in Breast, Ovarian, and Colorectal Cancers
National multicenter prospective study, involving the enrollment of approximately 1,500 patients with ovarian cancer, 1,500 patients with breast cancer, and 1,000 patients with colorectal cancer.
- Conditions
- Colon Cancer, Breast Cancer, Ovarian Cancer, Genetic Risk Factors
- Being tested
- Genomic profile
- Medical subject headings
- Colonic Neoplasms, Breast Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genomic profileGenetic
This national multicenter prospective study will use the ACC Gersom NGS gene panel (172 cancer risk genes, 295 tumor-altered genes, 196 pharmacogenomic variants) to perform parallel somatic (tumor) and germline (blood) testing in enrolled patients. After informed consent and pre-test genetic counseling, patients will undergo molecular analysis of tumor tissue (fresh or FFPE, ≥30% tumor content) and peripheral blood. All pathogenic variants, VUS, and actionable mutations identified will be validated using standard methods and, when necessary, discussed by the Molecular Tumor Board. Results will be returned through post-test genetic counseling, and treatment or surveillance decisions will be based on validated findings.
Blood samples (EDTA and Streck tubes) and tissue samples will be locally processed and biobanked, with centralized analyses performed in Candiolo for selected assays (RNA sequencing, microarray genotyping, CUTseq, and additional genomic analyses). The Gersom panel requir
| Study group | Role | What they receive |
|---|---|---|
| This national multicenter prospective study will use the ACC Gersom NGS gene panel (172 cancer risk | Experimental | This national multicenter prospective study will use the ACC Gersom NGS gene panel (172 cancer risk genes, 295 tumor-altered genes, 196 pharmacogenomic variants) to perform parallel somatic (tumor) and germline (blood) testing in enrolled patients. After informed consent and pre-test genetic counseling, patients will undergo molecular analysis of tumor tissue (fresh or FFPE, ≥30% tumor content) and peripheral blood. All pathogenic variants, VUS, and actionable mutations identified will be validated using standard methods and, when necessary, discussed by the Molecular Tumor Board. Results will be returned through post-test genetic counseling, and treatment or surveillance decisions will be based on validated findings.
Blood samples (EDTA and Streck tubes) and tissue samples will be locally processed and biobanked, with centralized analyses performed in Candiolo for selected assays (RNA sequencing, microarray genotyping, CUTseq, and additional genomic analyses). The Gersom panel requi Receives: Genetic: Genomic profile |
What is being measured
The primary outcome is the main question the study is designed to answer.
To validate the germline and somatic mutations with the Gersom panel.
The primary objective of the study will be to validate, using standard methodology, the germline and somatic mutations identified with the Gersom panel.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start21 Nov 2019
- Primary completion31 Dec 2022
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4,000 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NERO CAMILLA, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07555639
- Sponsor's protocol ID
- 2877
- Acronym
- GERSOM
- Status last verified
- Apr 2026
- First submitted
- 23 Feb 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study for Combined Genomic Diagnosis of Genetic Risk and Drug Sensitivity in Breast, Ovarian, and Colorectal Cancers
- ClinicalTrials.gov ID
- NCT07555639
- Acronym / sponsor ID
- GERSOM / 2877
- Conditions
- Colon Cancer, Breast Cancer, Ovarian Cancer, Genetic Risk Factors
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 4,000 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 21 Nov 2019 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 29 Apr 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.
National multicenter prospective study, involving the enrollment of approximately 1,500 patients with ovarian cancer, 1,500 patients with breast cancer, and 1,000 patients with colorectal cancer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| This national multicenter prospective study will use the ACC Gersom NGS gene panel (172 cancer risk | Experimental | Genetic: Genomic profileThis national multicenter prospective study will use the ACC Gersom NGS gene panel (172 cancer risk genes, 295 tumor-altered genes, 196 pharmacogenomic variants) to perform parallel somatic (tumor) and germline (blood) testing in enrolled patients. After informed consent and pre-test genetic counseling, patients will undergo molecular analysis of tumor tissue (fresh or FFPE, ≥30% tumor content) and peripheral blood. All pathogenic variants, VUS, and actionable mutations identified will be validated using standard methods and, when necessary, discussed by the Molecular Tumor Board. Results will be returned through post-test genetic counseling, and treatment or surveillance decisions will be based on validated findings. Blood samples (EDTA and Streck tubes) and tissue samples will be locally processed and biobanked, with centralized analyses performed in Candiolo for selected assays (RNA sequencing, microarray genotyping, CUTseq, and additional genomic analyses). The Gersom panel requi |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Ovary
- Newly diagnosed patients with epithelial ovarian, peritoneal, or fallopian tube tumors of any histology and stage, excluding borderline tumors, who are scheduled to undergo an invasive diagnostic or therapeutic procedure (surgery or biopsy). In the case of neoadjuvant therapy, availability of a pre-treatment biopsy sample is required.
- Age > 18 years.
- Written informed consent.
- Patients with recurrent disease, either untreated or treated with no more than one prior line of therapy, who are scheduled to undergo an invasive diagnostic or therapeutic procedure (surgery or biopsy), provided that paraffin-embedded tissue from the untreated primary tumor is available, not older than 2 years, and that a new pre-enrollment biopsy is feasible.
Key exclusion criteria (4 listed)
- Inability or unwillingness to undergo oncogenetic counseling;
- More than one prior line of chemotherapy (in any disease setting);
- For patients enrolled in the absence of active disease and identified during follow-up, unavailability of untreated tumor tissue obtained within the previous 2 years;
- For patients enrolled with active disease, tumor site not accessible for biopsy sampling.
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 |
|---|---|---|
| Genomic profileThis national multicenter prospective study will use the ACC Gersom NGS gene panel (172 cancer risk genes, 295 tumor-altered genes, 196 pharmacogenomic variants) to perform parallel somatic (tumor) and germline (blood) testing in enrolled patients. After informed consent and pre-test genetic counseling, patients will undergo molecular analysis of tumor tissue (fresh or FFPE, ≥30% tumor content) and peripheral blood. All pathogenic variants, VUS, and actionable mutations identified will be validated using standard methods and, when necessary, discussed by the Molecular Tumor Board. Results will be returned through post-test genetic counseling, and treatment or surveillance decisions will be based on validated findings. Blood samples (EDTA and Streck tubes) and tissue samples will be locally processed and biobanked, with centralized analyses performed in Candiolo for selected assays (RNA sequencing, microarray genotyping, CUTseq, and additional genomic analyses). The Gersom panel requir | Genetic | This national multicenter prospective study will use the ACC Gersom NGS gene panel (172 cancer risk |
Primary outcome
To validate the germline and somatic mutations with the Gersom panel.
Time frame: Baseline
The primary objective of the study will be to validate, using standard methodology, the germline and somatic mutations identified with the Gersom panel.
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 29 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Genomic profile in people with Colon Cancer and Breast Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 20 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 29 Apr 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 Italy. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To validate the germline and somatic mutations with the Gersom panel. (time frame: Baseline). 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 29 Apr 2026.