First CORRECT Study of Minimal Residual Disease (MRD) Detection in Colorectal Cancer
NCT ID: NCT06398743
Last Updated: 2025-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
416 participants
OBSERVATIONAL
2023-06-20
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Stage II or III
Patients with stage II or III colorectal cancer
MRD
ctDNA MRD test
Interventions
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MRD
ctDNA MRD test
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Fortrea
INDUSTRY
Exact Sciences Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Somasundaram Subramaniam, MD
Role: STUDY_DIRECTOR
Exact Sciences
Locations
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Tel Aviv Sourasky Medical Center
Tel Aviv Yaffo, Central District, Israel
Hillel Yaffe Medical Center
Hadera, North, Israel
Soroka University Medical Center
Beersheba, Southern District, Israel
HaEmek Medical Center
Afula, , Israel
Hadassah University Hospital - Mount Scopus
Jerusalem, , Israel
Shaare Zedek Medical Center Jerusalem
Jerusalem, , Israel
Istituto Clinico Humanitas
Rozzano, Milano, Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, , Italy
Istituto Nazionale Tumori - Fondazione G Pascale
Napoli, , Italy
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
Hokkaido Cancer Center
Sapporo, Hokkaido, Japan
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, United Kingdom
Edinburgh Cancer Centre
Edinburgh, Scotland, United Kingdom
Queen Elizabeth Hospital Birmingham
Birmingham, West Midlands, United Kingdom
Worcestershire Royal Hospital
Worcester, Worcestershire, United Kingdom
Ipswich Hospital
Ipswich, , United Kingdom
Kidderminster Hospital and Treatment Centre
Kidderminster, , United Kingdom
Alexandra Hospital
Redditch, , United Kingdom
Torbay Hospital
Torquay, , United Kingdom
Countries
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Other Identifiers
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16-001
Identifier Type: -
Identifier Source: org_study_id
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