A Prospective, Multicenter, Observational Registry of Metastatic Colorectal cancer (mCRC) Disease to determine Demographics, Clinical features, Molecularfeatures and Treatment outcomes in patients undergoing treatment at participating centers.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 1,000
- Locations
- 15
- Primary Endpoint
- To understand the clinical profile (e.g. Baseline demographics, Clinical presentations, co-morbid conditions, Performance
Study Overview
Brief Summary
This study is an multicenter, prospective Observational Registry study to determine Demographics, Clinical features, Molecular features and Treatment outcomes in patients undergoing treatment at participating centers who are ≥18 years that will be conducted in India. The objectives will be to understand the clinical profile, tumour characteristics, current treatment pattern of Metastatic Colorectal cancer (mCRC) patients and the outcomes in Metastatic Colorectal cancer (mCRC) patients undergoing treatment. Up to 1000 participants with Metastatic Colorectal Cancer to be enrolled in the Registry from up to 15 centres over a period of 2 years.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 99.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •ï‚· Metastatic adenocarcinoma of colon or rectum ï‚· Inoperable and eligible for first line systemic therapy ï‚· Age ≥ 18yrs.
- •ï‚· Signed informed consent.
Exclusion Criteria
- •ï‚· Any participants who received his or her treatment at participating study sites prior to enrolment except for patients with metachronous mCRC ï‚· Non-metastatic Colorectal cancer.
Outcomes
Primary Outcomes
To understand the clinical profile (e.g. Baseline demographics, Clinical presentations, co-morbid conditions, Performance
Time Frame: Baseline(Day 0), Follow up (3-6 months), follw up (12-18 months)
status etc.) of Metastatic Colorectal cancer (mCRC) patients undergoing treatment
Time Frame: Baseline(Day 0), Follow up (3-6 months), follw up (12-18 months)
ï‚· To understand the tumour characteristics (tumour location, Site of metastasis, Number of metastatic sites, Molecular profile [KRAS including KRAS G12C, BRAF, MSI/MSS, HER2 etc) of Metastatic Colorectal cancer (mCRC) patients undergoing
Time Frame: Baseline(Day 0), Follow up (3-6 months), follw up (12-18 months)
treatment.
Time Frame: Baseline(Day 0), Follow up (3-6 months), follw up (12-18 months)
ï‚· To understand the current treatment pattern of Metastatic Colorectal cancer (mCRC) patients
Time Frame: Baseline(Day 0), Follow up (3-6 months), follw up (12-18 months)
ï‚· To understand Treatment outcomes in Metastatic Colorectal cancer (mCRC) patients undergoing treatment
Time Frame: Baseline(Day 0), Follow up (3-6 months), follw up (12-18 months)
Secondary Outcomes
No secondary outcomes reported