Clinical trial · Observational
GEMCAD-REVEAL STUDY - Circulating Tumor DNA as a Predictor of Relapse in Patients With Locally Advanced Rectal Cancer.
Circulating Tumor DNA as a Predictor of Relapse in Patients With Locally Advanced Rectal Cancer Treated With Total Neoadjuvant Therapy Followed by Watch and Wait or Total Mesorectal Excision Based on Clinical Assessment of Response
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The evaluation of the tumor response to chemoradiotherapy/total neoadjuvant therapy (CRT/TNT) remains a challenge. The integration of a blood-based biomarker such as ctDNA with clinico-radiological tools could offer the potential advantage of improving accuracy of assessment of tumor response to neoadjuvant therapy. Furthermore, data on functional outcomes and quality of life after total mesorectal excision (TME) and especially after " Watch And Wait" (WW) is scarce. REVEAL is a prospective, multicenter study in which the response to TNT in correlation with liquid biopsy (LB) of patients with rectal cancer in Spain will be evaluated. It is planned to include 120 patients. All patients will be aged 18 years or older, with histologically confirmed rectal adenocarcinoma, located in the mid or distal third (with the inferior margin within 12cm from the anal verge), clinically staged II and III (cT3-T4 and/or any TN+), scheduled to undergo TNT will be eligible. All cases and treatment decisions will be discussed by local Multidisciplinary Boards. Patients will be included consecutively when visiting the corresponding health centers for outpatient visits or hospitalization. The objective of the present study is to evaluate the role of ctDNA in the prediction of relapse in patients diagnosed with locally advanced rectal cancer (LARC) treated with TNT followed by WW or TME based on a clinical assessment of the local response
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 |
|---|---|---|---|
| Patients With Locally Advanced Rectal Cancer | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| total neoadjuvant therapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- ctDNA from liquid biopsy
- timeFrame
- 2 years after to start treatment total neoadjuvant therapy/2 years per patient
- description
- The results from ctDNA will be dichotomized to positive or negative. The investigator will report the percentage of patients with positive or negative ctDNA. Correlation of these values with clinical endpoints of response / survival to total neoadjuvant therapy will be done to fulfill the proposed objectives of this study. The ctDNA isolation test selected for this study is marketed by Guardant Health (Redwood City, California, USA) under the name Guardant RevealTM. It consists of a single state-of-the-art liquid blood biopsy, which is capable of detecting residual or recurrent disease seven days after blood extraction. This test uses a sequencing method that simultaneously evaluates genetic alterations and methylation without the need for a biopsy of the primary tumor tissue to determine specific mutations.
Secondary outcomes (9)
- measure
- Response to TNT (cCR,nCCR)
- timeFrame
- Throughout the study period, approximately 2 years per patient
- description
- Number of patients will be classified as responders (cCR, nCCR) or non responders based on the International Consensus Recommendations for Organ Preservation in Rectal Cancer. The number and percentage of each category will be reported. cCR: clinical complete response nCCR: near-complete clinical response
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Legally capable patients ≥ 18 years of age. * Histologically confirmed rectal adenocarcinoma. * Any tumor located in the mid or distal rectum, clinically staged II-III (cT3/4 and/or any TN+). * Willingness to be enrolled in the WW strategy if cCR or nCCR is achieved. * Absence of metastases on imaging. * Scheduled to undergo TNT followed by delayed surgery. * Patients who have signed the informed consent for this study. Note: Decision was taken to treat the patient with a specific treatment prior and independently of patient inclusion in this non interventional study. Exclusion Criteria: * Patients who do not meet inclusion criteria. * Concomitant colorectal tumors. * Intolerance or contraindication to planned TNT. * Other concurrent malignant diseases. Pregnancy or breastfeeding.
References
Publications (0)
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