Clinical trial NCT06398743: First CORRECT Study of Minimal Residual Disease (MRD) Detection in Colorectal Cancer
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Colorectal Cancer
Keywords: Colorectal
ctDNA
Lead sponsor: Exact Sciences Corporation
Sponsor class: INDUSTRY
Collaborators: name: Fortrea
First posted: 2024-05-03
Enrollment: 416
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients over the age of 18 who have undergone surgery for stage II or III colorectal cancer

Brief 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 criteria: 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 outcomes:
measure: 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.
timeFrame: 6 years
Secondary outcomes:
measure: Time from the first ctDNA positivity to recurrence among subjects who have a positive ctDNA finding and have recurred.
timeFrame: 6 years
Other outcomes:
Locations:
city: Be'er Sheva
country: Israel
facility: Soroka University Medical Center
state: Hadarom
city: Tel Aviv Yaffo
country: Israel
facility: Tel Aviv Sourasky Medical Center
state: Hamerkaz
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
state: North
city: Afula
country: Israel
facility: HaEmek Medical Center
city: Jerusalem
country: Israel
facility: Hadassah University Hospital - Mount Scopus
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center Jerusalem
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Milano
city: Milano
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori - Fondazione G Pascale
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Sapporo
country: Japan
facility: Hokkaido Cancer Center
state: Hokkaido
city: Kita-gun
country: Japan
facility: Kagawa University Hospital
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Centro Integral Oncológico Clara Campal (HM CIOCC)
city: Headington
country: United Kingdom
facility: Churchill Hospital
state: Oxford
city: Edinburgh
country: United Kingdom
facility: Edinburgh Cancer Centre
state: Scotland
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital Birmingham
state: West Midlands
city: Worcester
country: United Kingdom
facility: Worcestershire Royal Hospital
state: Worcestershire
city: Ipswich
country: United Kingdom
facility: Ipswich Hospital
city: Kidderminster
country: United Kingdom
facility: Kidderminster Hospital and Treatment Centre
city: Redditch
country: United Kingdom
facility: Alexandra Hospital
city: Torquay
country: United Kingdom
facility: Torbay Hospital
Study officials:
affiliation: Exact Sciences
name: Melanie Palomares, MD
role: STUDY_DIRECTOR
References: