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

NCT05674422 | Active Not Recruiting

• 1 other identifier: GEMCAD 2201
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 15

Brief 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

Keywords

rectal cancer; ctDNA; total neoadjuvant therapy

Outcome Measures

Primary Outcomes (1)

• ctDNA from liquid biopsy

  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.

  2 years after to start treatment total neoadjuvant therapy/2 years per patient

Secondary Outcomes (9)

• Response to TNT (cCR,nCCR)

  Throughout the study period, approximately 2 years per patient

• Response to TNT (WW or TME)

  Throughout the study period, approximately 2 years per patient

• Locoregional failure rate (LRF)

  Throughout the study period, approximately 2 years per patient

• Distant relapse rate (DRR)

  Throughout the study period, approximately 2 years per patient

• Disease-free Survival (DFS)

  at 1 year after the first dose of TNT and at the end of study (approximately 2 years)

Interventions

total neoadjuvant therapy DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients diagnosed with locally advanced rectal cancer candidates to TNT. 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 enrolled patients will be allocated to receive TNT according to standard clinical practice.

You may qualify if:

• 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.

You may not qualify if:

• Concomitant colorectal tumors.
• Intolerance or contraindication to planned TNT.
• Other concurrent malignant diseases. Pregnancy or breastfeeding.

Sponsors & Collaborators

• Grupo Espanol Multidisciplinario del Cancer Digestivo: lead

Study Sites (15)

Hospital Germans Trias i Pujol - ICO Badalona

Badalona, Barcelona, Spain

Location

Hospital Universitari Mutua de Terrassa

Terrassa, Barcelona, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, Madrid, 28041, Spain

Location

H. de la Santa Creu i Sant Pau

Barcelona, Spain

Location

H.U. Vall d'Hebron

Barcelona, Spain

Location

Hospital Clínic, Universitat de Barcelona

Barcelona, Spain

Location

Hospital Del Mar, Barcelona

Barcelona, Spain

Location

Hospital Sant Joan Despí - Moisés Broggi.

Barcelona, Spain

Location

ICO-Hospitalet

Barcelona, Spain

Location

ICO Girona

Girona, Spain

Location

H. Univeristario La Paz

Madrid, Spain

Location

Hospital Quirón Salud Valencia

Valencia, Spain

Location

Hospital Universitari i Politècnic La Fe

Valencia, Spain

Location

Hospital Clínico Universitario Lozano Blesa

Zaragoza, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, Spain

Location

Biospecimen

Retention: SAMPLES WITH DNA

ctDNA from liquid biopsy: he 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.

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Yoelimar Guzmán, M.D.

  Servicio de Cirugía General y Digestiva, Hospital Clínic, Universitat de Barcelona

  STUDY CHAIR

• Joan Maurel Santasusana, M.D., Ph.D.

  Servicio de Oncología, Hospital Clínic, Universitat de Barcelona

  STUDY CHAIR

• Juan Ramón Ayuso, M.D., Ph.D.

  Servicio de Radiología, Hospital Clínic, Universitat de Barcelona

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2022
• First Posted: January 6, 2023
• Study Start: May 26, 2023
• Primary Completion: April 26, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: October 31, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (15)