Last reviewed · How we verify
NCT05255588
A Stool DNA-based SDC2 Methylation Test for the Early Detection of Colorectal Cancer
trial testing EarlyTect® CRC test in Colorectal Cancer in 2,358 participants. Completed in 30 August 2024.
23 May 2024
Quick facts
| Lead sponsor | Genomictree, Inc. |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 2,358 |
| Start date | 10 February 2022 |
| Primary completion | 23 May 2024 |
| Estimated completion | 30 August 2024 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- EarlyTect® CRC test
Conditions studied
- Colorectal Cancer — all drugs for Colorectal Cancer →
- Advanced Colorectal Neoplasm — all drugs for Advanced Colorectal Neoplasm →
- Advanced Adenomas — all drugs for Advanced Adenomas →
- Non-neoplastic Polyps — all drugs for Non-neoplastic Polyps →
Sponsor
Genomictree, Inc.
Who can join
40 and older, any sex, with Colorectal Cancer or Advanced Colorectal Neoplasm. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The primary objective of this clinical trial is to determine the sensitivity and specificity of the EarlyTect® CRC test for detecting CRC, using colonoscopy as the reference method. The secondary objective is to compare the clinical performance of EarlyTect® CRC test with a commercially available Fecal Immunochemical Test (FIT), with respect to CRC. By histopathological examination, lesions identified during colonoscopy will be confirmed as malignant or precancerous by histological examination.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05255588
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Colorectal Cancer
Currently open trials in the same condition.
- NCT07152821 — Botensilimab + Balstilimab vs Best Supportive Care as Therapy in Chemo-refractory, Unresectable, Colorectal Adenocarcino · Phase 3 · recruiting
- NCT07353645 — KRAS Neoantigen Nanovaccine as Adjuvant Therapy for Colorectal Cancer/Pancreatic Cancer · Phase 1, PHASE2 · recruiting
- NCT07432633 — [18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications · Phase 1, PHASE2 · recruiting
- NCT07523919 — Functional and Respiratory Determinants of Long-Term Colorectal Cancer Outcomes · recruiting
- NCT07529301 — Functional and Respiratory Predictors of Early Postoperative Outcomes · recruiting
Other Genomictree, Inc. trials
Trials by the same sponsor.
- NCT03146520 — Clinical Validation of Stool DNA-based SDC2 Methylation Test for Colorectal Cancer Detection · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05255588 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Genomictree, Inc.
- Last refreshed: 3 April 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05255588.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing