NCT04221854 is a NA clinical trial of Stool-based SDC2 DNA methylation test in Colorectal Cancer, sponsored by Sixth Affiliated Hospital, Sun Yat-sen University.

Who is sponsoring NCT04221854?

NCT04221854 is sponsored by Sixth Affiliated Hospital, Sun Yat-sen University.

What drugs are being tested in NCT04221854?

Interventions in NCT04221854: Stool-based SDC2 DNA methylation test, Fecal immunochemical test.

What condition does NCT04221854 study?

NCT04221854 studies Colorectal Cancer, Colorectal Adenomatous Polyp, Screening.

Is NCT04221854 still recruiting?

NCT04221854 is currently status unknown. Last updated 18 February 2020.

Last reviewed 2020-02-18 · How we verify

NCT04221854

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Stool-based SDC2 DNA Methylation Test for the Detection of Colorectal Advanced Adenomatous Polyps and Cancer

Status unknown NA Last updated 18 February 2020

What this trial tests

NA trial testing Stool-based SDC2 DNA methylation test in Colorectal Cancer in 50,000 participants. Status unknown.

Timeline

6 January 2020

Primary endpoint
31 December 2021

31 December 2021

Quick facts

Lead sponsor	Sixth Affiliated Hospital, Sun Yat-sen University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	screening
Enrollment	50,000
Start date	6 January 2020
Primary completion	31 December 2021
Estimated completion	31 December 2021
Sites	8 locations across China

Drugs / interventions tested

Stool-based SDC2 DNA methylation test
Fecal immunochemical test

Conditions studied

Colorectal Cancer — all drugs for Colorectal Cancer →
Colorectal Adenomatous Polyp — all drugs for Colorectal Adenomatous Polyp →
Screening — all drugs for Screening →

Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Who can join

Adults 45 to 80, any sex, with Colorectal Cancer or Colorectal Adenomatous Polyp. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The primary objective is to compare the performance of Stool-based SDC2 DNA Methylation Test and commercially available Fecal Immunochemical Test(FIT) , on the detection rate of advanced adenomatous polyps and colorectal cancer in Chinese population. Subjects with positive results in either test will receive colonoscopy. Lesions will be confirmed as malignant or precancerous by colonoscopy and histopathologic examination.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Targeting DNA methylation and demethylation in diabetic foot ulcers.
Deng JY, Wu XQ, He WJ, Liao X, et al · · 2023 · cited 35× · PMID 36706989 · DOI 10.1016/j.jare.2023.01.009
Stool-based methylated syndecan-2 test and fecal immunochemical test for advanced colorectal neoplasia screening in the Chinese population: A multicenter randomized noncomparative study.
Chen Y, Li J, Gu K, Ding K, et al · · 2025 · PMID 41334638 · DOI 10.1097/cm9.0000000000003897

Verify or expand the search:

Other trials of Stool-based SDC2 DNA methylation test

Trials testing the same drug.

NCT04786704 — A Stool DNA Test for Detection of Advanced Colorectal Neoplasia in Asymptomatic Chinese Community Population · completed

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 Sixth Affiliated Hospital, Sun Yat-sen University trials

Trials by the same sponsor.

NCT07538284 — MInimizing Delirium With Nasal Dexmedetomidine-InducEd Sleep (MIDDIES) · Phase 2, PHASE3 · not yet recruiting
NCT07176182 — Clinical Trial of Neoadjuvant mFOLFOX Plus Alvenor for LARC Patients With High YWHAB Expression · Phase 2 · not yet recruiting
NCT07510191 — TNFi Plus Low-Dose Upadacitinib vs TNFi Intensification in Crohn's Disease With Suboptimal Response · Phase 4 · recruiting
NCT07344428 — Efficacy and Safety of CDED With Anti-TNF-α Biologics in Crohn's Disease: A Randomized Trial · NA · not yet recruiting
NCT07328958 — Effect of Titrated Administration of Ciprofol on Perioperative Hypotension in Elderly Patients Undergoing Laparoscopic A · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04221854 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Sixth Affiliated Hospital, Sun Yat-sen University
Last refreshed: 18 February 2020

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/NCT04221854.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing