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The Implication of Plasma ctDNA Methylation Haplotypes in Detecting Colorectal Cancer and Adenomas

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ClinicalTrials.gov Identifier: NCT03737591
Recruitment Status : Recruiting
First Posted : November 9, 2018
Last Update Posted : November 9, 2018
Sponsor:
Collaborators:
Second Military Medical University
Shanghai University of Traditional Chinese Medicine
Information provided by (Responsible Party):
Guoxiang Cai, Fudan University

Brief Summary:
This is a prospective, 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.

Condition or disease Intervention/treatment
Colorectal Cancer Adenoma Diagnostic Test: Next-generation sequencing (NGS)

Detailed Description:
Colorectal cancer (CRC) is the third most common cancer worldwide, the second deadliest cancer in the United States. DNA methylation is a commonly used biomarker for non-invasive CRC detection in plasma. The low sensitivity of blood-based tests is due to several limitations of detecting ctDNA in early-stage cancer. We developed and validated a high-throughput methylation-based blood test highly sensitive for colorectal cancer and precancerous lesions. This previously established colorectal tumor-specific plasma ctDNA methylation markers (diagnostic model established by next-generation sequencing of 2181 gene loci methylation) had a high sensitivity in CRC patients and a high specificity in healthy individuals in a large retrospective sample study. This prospective, multicenter, clinical study is to further evaluate the sensitivity of plasma ctDNA methylation haplotypes in detecting colorectal cancer, adenoma and the specificity in healthy individuals.

Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Implication of Plasma Circulating Tumor DNA Methylation Haplotypes in Detecting Colorectal Cancer and Adenomas: a Prospective, Multicenter, Clinical Study
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Healthy individuals
Healthy individuals
Diagnostic Test: Next-generation sequencing (NGS)
NGS test for colorectal tumor-specific plasma ctDNA methylation markers prior to endoscopy

Patients with Colorectal cancer
Stage I-IV colorectal cancer patients
Diagnostic Test: Next-generation sequencing (NGS)
NGS test for colorectal tumor-specific plasma ctDNA methylation markers prior to endoscopy

Patients with Colorectal Adenomas
Patients with Colorectal Adenomas
Diagnostic Test: Next-generation sequencing (NGS)
NGS test for colorectal tumor-specific plasma ctDNA methylation markers prior to endoscopy




Primary Outcome Measures :
  1. Sensitivity [ Time Frame: 2 years ]
    The sensitivity of plasma ctDNA methylation haplotypes in detecting colorectal cancer and adenoma

  2. Specificity [ Time Frame: 2 years ]
    The specificity of plasma ctDNA methylation haplotypes in healthy individuals



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-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.
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03737591


Contacts
Contact: Guoxiang Cai, M.D. Ph.D. +86 13611831623 gxcai@fudan.edu.cn

Locations
China
Fudan University Shanghai Cancer Center Recruiting
Shanghai, China, 200032
Contact: Guoxiang Cai, M.D. Ph.D.         
Sponsors and Collaborators
Fudan University
Second Military Medical University
Shanghai University of Traditional Chinese Medicine

Responsible Party: Guoxiang Cai, Professor, Fudan University
ClinicalTrials.gov Identifier: NCT03737591     History of Changes
Other Study ID Numbers: FDCRCA-CGX
First Posted: November 9, 2018    Key Record Dates
Last Update Posted: November 9, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Guoxiang Cai, Fudan University:
Colorectal Cancer
Adenomas
ctDNA Methylation Haplotypes

Additional relevant MeSH terms:
Colorectal Neoplasms
Adenoma
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type