The mCRC Patients With pMMR/MSS or dMMR/MSI-H Status Received Palliative Chemotherapy Efficacy and Survival

NCT04482608 | Completed

• 1 other identifier: dMMR/MSI-H and chemotherapy
• Study Type: observational
• Target: 671
• Locations: 1 country
• Sites: 1

Brief Summary

Deficient mismatch repair (dMMR) or microsatellite instability high (MSI-H) accounts for 4-5% in metastatic colorectal cancer (mCRC). The efficacy and survival of patients with dMMR/MSI-H status received palliative chemotherapy have not clear yet. In this study, the investigators observed the efficacy and survival of dMMR/MSI-H status mCRC patients received palliative first-line chemotherapy.

Conditions

Colorectal Cancer Metastatic; Mismatch Repair Deficiency; Microsatellite Instability High

Keywords

Colorectal Cancer Metastatic; Mismatch Repair Deficiency; Microsatellite Instability High; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  PFS as measured in accordance with the Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1

  up to 24-36 months

Secondary Outcomes (3)

• Response rate

  From first patient first visit to 6 month after last patient first visit

• Disease Control Rate (DCR)

  From first patient first visit to 6 month after last patient first visit

• Overall survival

  up to approximately 9 year

Study Arms (2)

pMMR/MSS mCRC patients

The metastatic colorectal cancer patients with proficient mismatch repair or microsatellite stable status.

dMMR/MSI-H mCRC patients

The metastatic colorectal cancer patients with deficient mismatch repair or microsatellite instability high status.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The metastatic colorectal patients with different MMR or microsatellite status received palliative chemotherapy

You may qualify if:

• Age ≥ 18 years old
• Histologically confirmed Metastatic colorectal adenocarcinoma;
• Immunohistochemistry confirmed mismatch repair status or polymerase chain reaction (pCR) / next-generation sequencing (NGS) confirmed microsatellite status
• Received palliative chemotherapy and have complete information of treatment

You may not qualify if:

• Patients have not tested for mismatch repair or microsatellite
• Patients have not received palliative chemotherapy or received palliative chemotherapy but treatment information incomplete

Sponsors & Collaborators

• Sun Yat-sen University: lead
• The Second Affiliated Hospital of Kunming Medical University: collaborator

Study Sites (1)

Sun yat-sen university cancer center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Turcot syndrome

Study Officials

• Ying Jin, MD.,PhD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: July 18, 2020
• First Posted: July 22, 2020
• Study Start: September 1, 2019
• Primary Completion: April 1, 2020
• Study Completion: June 8, 2020
• Last Updated: July 27, 2020

Record last verified: 2020-07

Locations

CN (1)