Clinical trial · Observational
Observational Study on Rectal Cancer to Verify if Response After Chemo-radiotherapy Can be Predicted With a Particular Blood Test.
A Proof-of-concept, Prospective, Observational Study to Investigate the Value of Liquid Biopsies to Predict Tumor Response After Neoadjuvant Chemo-radiotherapy in Patients With Locally Advanced Rectal Cancer: the LiBReCa Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): failure to identify complete responders since ctDNA disappears after radiotherapy in most patients.
Summary
Brief summary (as posted)
Research project for patients with locally advanced rectal cancer in which biological material and health-related personal data are collected. The aim is to investigate if an additional method (liquid biopsies) can predict the response after chemo-radiotherapy and before surgery.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Rectal Cancer | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Neoadjuvant chemotherapy | Drug | — | UNRESOLVED |
| Neoadjuvant radiotherapy | Radiation | — | UNRESOLVED |
| Radical surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Negative Prognostic Value (NPV)
- timeFrame
- day of surgery
- description
- NPV of the liquid biopsy of ctDNA drawn from the mesenteric and peripheral blood
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years old * Locally advanced rectal cancer (T3 or T4, and/or N+) requiring long course nCRT (as decided by the regional tumor board) * Patient fit for surgery and treated with curative intent * Willingness to complete all clinical and radiological examinations foreseen by the study * Availability of tissue specimen for molecular characterization at baseline * Written informed consent Exclusion Criteria: * Presence of metastases * Insufficient material on the tissue biopsy to be left in archives of the Cantonal Institute of Pathology for further evaluations/analyses * Insufficient amount of tumor cells in the tissue biopsy for the molecular characterization * Inability to consent and follow the procedures of the study * Women who are pregnant or breast feeding
References
Publications (0)
Data not yet available