Ireland
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Active, not recruiting Observational

First CORRECT Study of Minimal Residual Disease (MRD) Detection in Colorectal Cancer

NCT06398743 · tracked via the Priya Life Science Spain tracker
Phase
Observational
Started
2023-06-20
Last updated
2025-07-24

Condition(s) studied

Colorectal Cancer

Investigational drug(s) / intervention(s)

MRD

MRD: ctDNA MRD test

Study summary

The CORRECT - MRD I study will prospectively enroll patients who have undergone complete surgical resection for stage II or III colorectal cancer. Patients will be followed for up to 5 years for recurrence.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: Subject is/has: 1. 18 years of age or older. 2. Diagnosis of carcinoma of the colon or rectum (patients with lymphomatous, sarcomatous,or neuroendocrine features are not eligible). 3. Post complete surgical resection of CRC, with last surgery occurring within 180 days prior to enrollment are eligible if all of the following conditions are met: 1. in the opinion of the surgeon, all grossly visible tumor was completely resected ("curative resection") and 2. histologic evaluation by the pathologist confirms the margins of the resected specimens are not involved by malignant cells. i. Patients with T4 tumors that have involved an adjacent structure (e.g., bladder, small intestine, ovary, etc.) by direct extension form the primary tumor must have had all or a portion of the adjacent structure removed en bloc with the primary tumor and local radiation therapy will not be utilized. 4. Pathologic Stage II or III CRC. 5. ECOG performance status ≤ 2 (0, 1 or 2). 6. Able to understand and provide written informed consent. 7. Willing and able to comply with the study requirements, which includes the collection of approximately 35mL of blood for each research blood draw. Exclusion Criteria: Subject is/has: 1. Initiated adjuvant therapy for current CRC diagnosis (note: neoadjuvant therapy acceptable). 2. Known pregnancy or breastfeeding at time of enrollment. 3. Prior history of any invasive cancer (including CRC) within the past 3 years prior to informed consent, with the exception of non-melanoma skin cancer. Patients with a prior history of noninvasive (in situ) carcinomas may participate after definitive treatment. 4. Prior transplant history: 1. Prior allogeneic hematopoietic stem cell transplant at any time. 2. Prior solid organ transplant within the last 2 years prior to enrollment. 5. Multiple cancer diagnoses: Synchronous or asynchronous diagnoses (or suspicion) of multiple primary cancers at the time of eligibility screening.

Primary outcome measure(s)

  • To validate the association of post-definitive therapy and pre-recurrence follow-up ctDNA positivity with Recurrence Free Interval, defined as elapsed time from surgical resection to the first clinical recurrence or CRC-related death. — 6 years

Trial sites (22)

FacilityCityRegionStatus
Tel Aviv Sourasky Medical Center Tel Aviv Yaffo Central District
Hillel Yaffe Medical Center Hadera North
Soroka University Medical Center Beersheba Southern District
HaEmek Medical Center Afula Israel
Hadassah University Hospital - Mount Scopus Jerusalem Israel
Shaare Zedek Medical Center Jerusalem Jerusalem Israel
Istituto Clinico Humanitas Rozzano Milano
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Istituto Nazionale Tumori - Fondazione G Pascale Naples Italy
National Cancer Center Hospital East Kashiwa Chiba
Hokkaido Cancer Center Sapporo Hokkaido
Kagawa University Hospital Kita-gun Japan
Hospital Universitario La Paz Madrid Spain
Centro Integral Oncológico Clara Campal (HM CIOCC) Madrid Spain
Churchill Hospital Headington Oxford
Edinburgh Cancer Centre Edinburgh Scotland
Queen Elizabeth Hospital Birmingham Birmingham West Midlands
Worcestershire Royal Hospital Worcester Worcestershire
Ipswich Hospital Ipswich United Kingdom
Kidderminster Hospital and Treatment Centre Kidderminster United Kingdom
Alexandra Hospital Redditch United Kingdom
Torbay Hospital Torquay United Kingdom
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06398743 on ClinicalTrials.gov ↗ ← All trials in Spain