NCT03737591

Brief Summary

This is a multicenter, clinical study. This study is to evaluate the sensitivity of plasma ctDNA methylation haplotypes in detecting colorectal cancer, adenoma and the specificity in healthy individuals.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,138

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
8.5 years until next milestone

First Submitted

Initial submission to the registry

November 8, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 9, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

January 25, 2022

Status Verified

January 1, 2022

Enrollment Period

8.7 years

First QC Date

November 8, 2018

Last Update Submit

January 9, 2022

Conditions

Colorectal CancerAdenoma

Keywords

Colorectal CancerAdenomasctDNA Methylation Haplotypes

Outcome Measures

Primary Outcomes (2)

  • Sensitivity

    The sensitivity of plasma ctDNA methylation haplotypes in detecting colorectal cancer and adenoma

    2 years

  • Specificity

    The specificity of plasma ctDNA methylation haplotypes in healthy individuals

    2 years

Study Arms (3)

Healthy individuals

Healthy individuals

Diagnostic Test: Next-generation sequencing (NGS)

Patients with Colorectal cancer

Stage I-IV colorectal cancer patients

Diagnostic Test: Next-generation sequencing (NGS)

Patients with Colorectal Adenomas

Patients with Colorectal Adenomas

Diagnostic Test: Next-generation sequencing (NGS)

Interventions

Next-generation sequencing (NGS)DIAGNOSTIC_TEST

NGS test for colorectal tumor-specific plasma ctDNA methylation markers prior to endoscopy

Healthy individualsPatients with Colorectal AdenomasPatients with Colorectal cancer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy individuals and patients with stage I-IV colorectal cancer or adenomas must have baseline evaluations performed prior to the study and must meet all inclusion and exclusion criteria. In addition, the patient must be thoroughly informed about all aspects of the study, including the study visit schedule and required evaluations and all regulatory requirements for informed consent.

You may qualify if:

  • Healthy Individuals:
  • Written informed consent must be obtained from healthy individuals to comply with the requirements of the study.
  • Healthy individuals who received colonoscopy.
  • Patients with Colorectal Cancer or Adenomas:
  • Male or female ≥ 18 years of age on the day of signing informed consent.
  • Patients need to receive surgical resection or endoscopic resection.
  • Patients must have histologically confirmed stage I-IV colorectal cancer or adenomas
  • Patients must have a performance status of ≤1 on the ECOG Performance Scale.
  • Written informed consent must be obtained from patient or patient's legal representative and ability for patient to comply with the requirements of the study.

You may not qualify if:

  • Patients received adjuvant treatment prior to the surgical resection.
  • Patients received blood transfusion two weeks before or during the surgical resection.
  • Patients with unresected advanced colorectal adenoma.
  • Patients who are positive for Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C.
  • Patients who are pregnant.
  • Patients who are alcoholic or drug abusers.
  • Patients with a history or current evidence of any condition or abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the Investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, 200032, China

Location

Related Publications (1)

  • Mo S, Dai W, Wang H, Lan X, Ma C, Su Z, Xiang W, Han L, Luo W, Zhang L, Wang R, Zhang Y, Zhang W, Yang L, Lu R, Guo L, Zheng Y, Huang M, Xu Y, Liang L, Cai S, Cai G. Early detection and prognosis prediction for colorectal cancer by circulating tumour DNA methylation haplotypes: A multicentre cohort study. EClinicalMedicine. 2022 Nov 3;55:101717. doi: 10.1016/j.eclinm.2022.101717. eCollection 2023 Jan.

    PMID: 36386039DERIVED

MeSH Terms

Conditions

Colorectal NeoplasmsAdenoma

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 8, 2018

First Posted

November 9, 2018

Study Start

May 1, 2010

Primary Completion

December 31, 2018

Study Completion

December 31, 2021

Last Updated

January 25, 2022

Record last verified: 2022-01

Locations

CN(1)