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

Colorectal Cancer Clinical Trial

— MRD  

Official title:

CORRECT-MRD I: First Colorectal Cancer Clinical Validation Study to Predict Recurrence Using a Circulating Tumor DNA Assay to Detect Minimal Residual Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06398743
• Other study ID #: 16-001
• Status: Recruiting
• Start date: June 20, 2023
• Est. completion date: June 15, 2029

Study information

• Verified date: June 2023
• Source: Exact Sciences Corporation
• Contact: Melanie Palomares, MD
• Phone: 650-569-2482
• Email: mpalomares[@]exactsciences.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: June 15, 2029
• Est. primary completion date: June 15, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Neoplasm, Residual

Intervention

Device:
• MRD
ctDNA MRD test

Locations

Country	Name	City	State
Israel	HaEmek Medical Center	Afula	North
Israel	Hadassah Medical Center	Jerusalem
Italy	ASST Grande Ospedale Metropolitano Niguarda	Milano
Italy	Istituto Nazionale Tumori - Fondazione G Pascale	Napoli
Italy	Istituto Clinico Humanitas	Rozzano	Milano
Spain	Centro Integral Oncológico Clara Campal (HM CIOCC)	Madrid
Spain	Hospital Universitario La Paz	Madrid
United Kingdom	Edinburgh Cancer Centre	Edinburgh	Scotland
United Kingdom	Ipswich Hospital	Ipswich
United Kingdom	Torbay Hospital	Torquay

Sponsors (2)

Lead Sponsor	Collaborator
Exact Sciences Corporation	Labcorp Corporation of America Holdings, Inc

Countries where clinical trial is conducted

Israel,  Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Time from the first ctDNA positivity to recurrence among subjects who have a positive ctDNA finding and have recurred.		6 years