NCT07619859Active, not recruiting
Impact of Fusobacterium Nucleatum on Response to Anti-EGFR Therapy in Metastatic Colorectal Cancer
Association Between Intratumoral Fusobacterium Nucleatum Burden and Therapeutic Resistance to Anti-EGFR Monoclonal Antibodies in Metastatic Colorectal Cancer: An Integrated Analysis of Clinical and Molecular Data
Source: ClinicalTrials.gov · Last updated 4 Jun 2026
Brief summary (registry, in English)
This retrospective observational cohort study investigates the association between the intratumoral burden of the bacterium Fusobacterium nucleatum (Fn) and the efficacy of anti-EGFR targeted therapies (cetuximab or panitumumab) in patients with RAS wild-type metastatic colorectal cancer (mCRC). Bacterial quantification will be performed using droplet digital polymerase chain reaction (ddPCR) on formalin-fixed, paraffin-embedded (FFPE) tissue samples, comprising an estimated cohort of 500 patients.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 500 (estimated)
- First submitted
- 7 May 2026
- Start date
- 5 Jul 2024
- Primary completion date
- 10 Dec 2027
- Lead sponsor
- Barretos Cancer Hospital
- Diseases
- Colorectal cancer
- NCT number
- NCT07619859
What you commit to
- Study type: Observational
- Planned participants: 500
- From 5 Jul 2024 to the primary completion date, 10 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- Presence of BRAF gene mutation (except for patients who received anti-EGFR therapy combined with BRAF inhibitors, according to standard clinical practice for this subgroup).
Other
- Primary tumor originating in sites other than the colon or rectum.
- Presence of activating mutations in KRAS or NRAS genes.
- Tumor histology other than adenocarcinoma.
- Insufficient clinical or follow-up data in medical records for the evaluation of the study's primary endpoints
Who the study is looking for
- Histologically confirmed diagnosis of metastatic (Stage IV) adenocarcinoma of the colon or rectum.
- Received at least one cycle of anti-EGFR therapy (cetuximab or panitumumab), either as monotherapy or in combination regimens, regardless of the line of therapy.
- Anti-EGFR therapy administered between January 2016 and December 2022.
- Availability of formalin-fixed paraffin-embedded (FFPE) tumor tissue blocks (from primary tumor or metastatic site) stored in the institutional biobank, with adequate quality for molecular analysis
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Barretos Cancer Hospital Coordinator of this site? Confirm its status | Barretos | Brazil | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.