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ctDNA Methylation Application in Postoperative Relapse and Adjuvant Chemotherapy Efficacy Evaluation

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ClinicalTrials.gov Identifier: NCT05536089
Recruitment Status : Recruiting
First Posted : September 10, 2022
Last Update Posted : October 26, 2022
Sponsor:
Collaborator:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Information provided by (Responsible Party):
Singlera Genomics Inc.

Study Description
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Brief Summary:
In this study, the investigators aimed to apply their previously developed multi-locus blood-based assay targeting circulating tumor DNA methylation to monitor postoperative relapse and evaluate adjuvant chemotherapy efficacy in resected stage I and stage II (without high risk) colorectal cancer after radical resection.

Condition or disease Intervention/treatment
Cancer Colorectal Diagnostic Test: a multi-locus blood-based assay

Detailed Description:
This is a prospective, multicenter, observational, real-world study. Research objects: patients with surgically resectable colorectal cancer and ctDNA positive before surgery in stage I and stage II (without high risk). After giving fully informed consent, the participants will undergo the regular treatment according to NCCN guidelines. Serial analysis of ctDNA will be performed at specific time points including pre-treatment, postoperative week 3, postoperative 5 years ( every 3 months for the first 2 years, and every 6 months for the rest 3 years). Participants will be observed and examined during the follow-up period.
Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: ctDNA Methylation Used to Monitor Postoperative Relapse and Evaluate Adjuvant Chemotherapy Efficacy in Resected Stage I and Stage II (Without High Risk) Colorectal Cancer After Radical Resection
Actual Study Start Date : September 5, 2022
Estimated Primary Completion Date : September 2028
Estimated Study Completion Date : December 2028
Groups and Cohorts
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Group/Cohort Intervention/treatment
ctDNA positive
Postoperative ctDNA positive
 Diagnostic Test: a multi-locus blood-based assay
Colorectal tumor-specific plasma ctDNA methylation markers detection
ctDNA negative
Postoperative ctDNA negative
 Diagnostic Test: a multi-locus blood-based assay
Colorectal tumor-specific plasma ctDNA methylation markers detection


Outcome Measures
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Primary Outcome Measures :
  1. 5y DFS [ Time Frame: 5 years ]
    The 5-year disease free survival rate of the patients from both cohorts.

  2. ctDNA methylation markers versus CT/MRI [ Time Frame: 5 years ]
    ctDNA methylation predictors of outcome will be compared to CT/MRI


Secondary Outcome Measures :
  1. 3y DFS [ Time Frame: 3 years ]
    The 3-year disease free survival rate of the patients from both cohorts.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients 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. The written informed consent must be obtained from the patient prior to enrollment. The following criteria apply to all patients enrolled onto the study unless otherwise specified.
Criteria

Inclusion Criteria:

  • Patients must have histologically confirmed stage I/II (without high risk) colorectal cancer.
  • Male or female ≥ 18 years of age on the day of signing informed consent.
  • Patients need to receive surgical resection, and with ctDNA positive prior to resection of colorectal cancer (CRC).
  • Patients must have a performance status of ≤1 on the Eastern Cooperative Oncology Group (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:

  • Personal history of colorectal cancer, colorectal adenoma or aerodigestive tract cancer.
  • Induction of neoadjuvant systemic therapy prior to resection of CRC.
  • Patient is pregnant or lactating.
  • 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.
  • Inadequate tumor material (either quality and quantity) to support circulating tumor DNA (ctDNA) analysis.
Contacts and Locations
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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): NCT05536089


Contacts
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Contact: HongFeng cao, Ph.D 13957117804 hongfengcao@zju.edu.cn
Contact: Rui Liu, Ph.D rliu@singleragenomics.com

Locations
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China, Zhejiang
Second Affiliated Hospital Recruiting
Hangzhou, Zhejiang, China, 310009
Contact: HongFeng Cao, Ph.D    13957117804    hongfengcao@zju.edu.cn   
Sponsors and Collaborators
Singlera Genomics Inc.
Second Affiliated Hospital, School of Medicine, Zhejiang University
Investigators
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Study Director: KeFeng Ding, Ph.D Second Affiliated Hospital, School of Medicine, Zhejiang University
Principal Investigator: Rui Liu, Ph.D Singlera Genomics Inc.
More Information
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Publications of Results:

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Responsible Party: Singlera Genomics Inc.
ClinicalTrials.gov Identifier: NCT05536089    
Other Study ID Numbers: IR2022284
First Posted: September 10, 2022    Key Record Dates
Last Update Posted: October 26, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Singlera Genomics Inc.:
early detection
Additional relevant MeSH terms:
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Recurrence
Disease Attributes
Pathologic Processes