Identifying MSI Status From ctDNA in Chinese Patients With Refractory Advanced Solid Tumors
IMPACT
Identifying Microsatellite Instability Status From Circulating Tumor DNA in Chinese Patients With Refractory Advanced Solid Tumors: a Large Molecular Epidemiological Investigation
1 other identifier
interventional
8,000
1 country
1
Brief Summary
This is a molecular epidemiological investigation aiming to identify microsatellite instability status from circulating tumor DNA in Chinese patients with refractory advanced solid tumors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 27, 2018
CompletedStudy Start
First participant enrolled
July 11, 2018
CompletedFirst Posted
Study publicly available on registry
July 24, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedJuly 24, 2018
July 1, 2018
1.9 years
June 27, 2018
July 12, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of MSI-H across different cancer types in Chinese patients
Two years
Secondary Outcomes (2)
Incidence of Lynch syndrome across different cancer types
Two years
Concordance between blood-MSI and corresponding tissue-MSI status
Two years
Study Arms (1)
Experimental group
EXPERIMENTALA total of 8-10 mL of blood will be collected from this group of patients and used for blood-MSI testing.
Interventions
SPANOM technique, which has been developed by 3D Medicines Inc. Shanghai, China and made it possible to identify MSI status from blood samples, will be used in patients with refractory advanced solid tumors.
Eligibility Criteria
You may qualify if:
- Male or female, age≥18 years old.
- Confirmed malignant solid tumor by histopathology or cytopathology.
- Colorectal cancer: progression after second-line therapy. Non-colorectal cancer: progression after first-line therapy.
- Time duration from the last time of anti-cancer treatment to blood sample collection for MSI testing ≥ two weeks or five times half-life period of anti-cancer drugs
- Signed the informed consent with name and time.
You may not qualify if:
- Hematological malignancy
- Patients who received immuotherapies.
- Patients who received blood transfusion within one month before blood collection.
- Pregnancy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Related Publications (1)
Zhenghang Wang, Hao Qin, Mei Wang, et al. SPANOM: A cost-effective method of detecting MSI in ctDNA. ASCO 2018, abstract e24263.
BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Shen Lin, Professor
Peking University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 27, 2018
First Posted
July 24, 2018
Study Start
July 11, 2018
Primary Completion
June 1, 2020
Study Completion
June 1, 2020
Last Updated
July 24, 2018
Record last verified: 2018-07
Data Sharing
- IPD Sharing
- Will not share