MedTrace Logo

GEMCAD-REVEAL STUDY - Circulating Tumor DNA as a Predictor of Relapse in Patients With Locally Advanced Rectal Cancer.

NCT05674422 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2024-10-31

No results posted yet for this study

Summary

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

  • Patients With Locally Advanced Rectal Cancer

Interventions

DRUG

total neoadjuvant therapy

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

Sponsors & Collaborators

  • Grupo Espanol Multidisciplinario del Cancer Digestivo

    lead OTHER

Principal Investigators

  • Yoelimar Guzmán, M.D. · Servicio de Cirugía General y Digestiva, Hospital Clínic, Universitat de Barcelona

  • Joan Maurel Santasusana, M.D., Ph.D. · Servicio de Oncología, Hospital Clínic, Universitat de Barcelona

  • Juan Ramón Ayuso, M.D., Ph.D. · Servicio de Radiología, Hospital Clínic, Universitat de Barcelona

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-26
Primary Completion
2025-04-26
Completion
2026-07-31

Countries

  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05674422 on ClinicalTrials.gov