Identifying MSI Status From ctDNA in Chinese Patients With Refractory Advanced Solid Tumors

Solid Tumor Clinical Trial

— IMPACT  

Official title:

Identifying Microsatellite Instability Status From Circulating Tumor DNA in Chinese Patients With Refractory Advanced Solid Tumors: a Large Molecular Epidemiological Investigation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03596593
• Other study ID #: IMPACT-China
• Status: Recruiting
• Phase: N/A
• Start date: July 11, 2018
• Est. completion date: June 2020

Study information

• Verified date: July 2018
• Source: Peking University
• Contact: Shen Lin, Professor
• Phone: 010-88196561
• Email: Linshenpku[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This study is conducted in Chinese patients with advanced refractory metastatic solid tumors. A total of 8-10 mL of blood will be collected from eligible patients and used for extracting circulating tumor DNA. Blood-MSI status will be tested based on SPANOM technique developed by 3D Medicines Inc. Shanghai, China. Patients are encouraged to provide tissues collected from progressive disease for tissue-MSI testing (not required for inclusion).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8000
• Est. completion date: June 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Male or female, age=18 years old.

2. Confirmed malignant solid tumor by histopathology or cytopathology.

3. Colorectal cancer: progression after second-line therapy. Non-colorectal cancer:

progression after first-line therapy.

4. 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

5. Signed the informed consent with name and time.

Exclusion Criteria:

1. Hematological malignancy

2. Patients who received immuotherapies.

3. Patients who received blood transfusion within one month before blood collection.

4. Pregnancy.

Related Conditions & MeSH terms

• Microsatellite Instability
• Solid Tumor

Intervention

Diagnostic Test:
• SPANOM (identifying MSI status from ctDNA)
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.

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

References & Publications (1)

Zhenghang Wang, Hao Qin, Mei Wang, et al. SPANOM: A cost-effective method of detecting MSI in ctDNA. ASCO 2018, abstract e24263.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of MSI-H across different cancer types in Chinese patients		Two years
Secondary	Incidence of Lynch syndrome across different cancer types		Two years
Secondary	Concordance between blood-MSI and corresponding tissue-MSI status	In patients who are able to provide tumor tissue samples, concordance between blood-MSI status by SPANOM technique and tissue-MSI status by polymerase chain reaction (PCR) method will be calculated.; DNA extracted from each tumor tissue will be amplified by standard PCR using six microsatellite loci: NR-21, BA-26, NR-27, BA-25, NR-24, MONO-27. Tumors are designated MSI-H if more than two loci were instable, MSI-L if one locus is instable, and MSS if all loci are stable.	Two years