Clinical Trials in Spain / NCT06398743
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
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
Other trials for the same condition
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