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| Name | Class |
|---|---|
| Fortrea | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stage II or III | Patients with stage II or III colorectal cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRD | Device | ctDNA MRD test |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Time from the first ctDNA positivity to recurrence among subjects who have a positive ctDNA finding and have recurred. | 6 years |
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Inclusion Criteria:
Subject is/has:
18 years of age or older.
Diagnosis of carcinoma of the colon or rectum (patients with lymphomatous, sarcomatous,or neuroendocrine features are not eligible).
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:
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.
Pathologic Stage II or III CRC.
ECOG performance status ≤ 2 (0, 1 or 2).
Able to understand and provide written informed consent.
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:
Initiated adjuvant therapy for current CRC diagnosis (note: neoadjuvant therapy acceptable).
Known pregnancy or breastfeeding at time of enrollment.
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.
Prior transplant history:
Multiple cancer diagnoses: Synchronous or asynchronous diagnoses (or suspicion) of multiple primary cancers at the time of eligibility screening.
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Patients over the age of 18 who have undergone surgery for stage II or III colorectal cancer
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| Name | Affiliation | Role |
|---|---|---|
| Somasundaram Subramaniam, MD | Exact Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tel Aviv Sourasky Medical Center | Tel Aviv Yaffo | Central District | 64239 | Israel | ||
| Hillel Yaffe Medical Center |
Individual participant data that underlie the results reported in publications of the study will be shared after deidentification. This may include test, tables, figured, and appendices. The study protocol, statistical analysis plan (when applicable), informed consent form (when applicable). May not be reproduced nor disseminated outside of Exact Sciences without permission and the clinical study report (when applicable) will also be shared
Data will be available from 2 years and ending 4 years after publication
Proposals for access to data should be directed to clinicaltrials@exactsciences.com. To gain access, data requestors will need to provide a methodologically sound proposal and sign a data access agreement. Researchers are required to obtain necessary institutional review board/independent ethics committee approvals or waivers as applicable to conduct research.
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| Hadera |
| North |
| 3846201 |
| Israel |
| Soroka University Medical Center | Beersheba | Southern District | 8410101 | Israel |
| HaEmek Medical Center | Afula | 1834111 | Israel |
| Hadassah University Hospital - Mount Scopus | Jerusalem | 12000 | Israel |
| Shaare Zedek Medical Center Jerusalem | Jerusalem | 9312584 | Israel |
| Istituto Clinico Humanitas | Rozzano | Milano | 20089 | Italy |
| ASST Grande Ospedale Metropolitano Niguarda | Milan | 20262 | Italy |
| Istituto Nazionale Tumori - Fondazione G Pascale | Naples | 20162 | Italy |
| National Cancer Center Hospital East | Kashiwa | Chiba | 277-8577 | Japan |
| Hokkaido Cancer Center | Sapporo | Hokkaido | 003-0804 | Japan |
| Kagawa University Hospital | Kita-gun | 7610793 | Japan |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Centro Integral Oncológico Clara Campal (HM CIOCC) | Madrid | 28050 | Spain |
| Churchill Hospital | Headington | Oxford | OX3 7LE | United Kingdom |
| Edinburgh Cancer Centre | Edinburgh | Scotland | EH4 3NQ | United Kingdom |
| Queen Elizabeth Hospital Birmingham | Birmingham | West Midlands | B15 2TH | United Kingdom |
| Worcestershire Royal Hospital | Worcester | Worcestershire | WR5 1DD | United Kingdom |
| Ipswich Hospital | Ipswich | IP4 5PD | United Kingdom |
| Kidderminster Hospital and Treatment Centre | Kidderminster | DY11 6RJ | United Kingdom |
| Alexandra Hospital | Redditch | B98 7UB | United Kingdom |
| Torbay Hospital | Torquay | TQ2 7AA | United Kingdom |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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