Molecular Characteristics of Early-onset Compared With Late-onset Colorectal Cancer

NCT06238193 | Completed DMC

• 1 other identifier: PRSYM202401
• Study Type: observational
• Target: 11,344
• Locations: 0 countries
• Sites: N/A

Brief Summary

The distribution rate of microsatellite instability-high (MSI-H) was significantly higher in early-onset colorectal cancer, and early-onset colorectal cancer has a specific mutational profile and relatively high programmed cell death ligand 1(PD-L1) expression, which may be used to guide personalized treatment to better control the disease.

Conditions

Colorectal Cancer; Microsatellite Instability

Outcome Measures

Primary Outcomes (1)

• MSI status

  (I) MSI-High (MSI-H) if two or more mononucleotide markers in tumor tissue had size variations of ≥3bp compared to normal tissue; (II) MSI-Low (MSI-L) if a single mononucleotide marker in tumor tissue exhibited a size variation of ≥3bp compared to normal tissue; (III) Microsatellite Stable (MSS) if there were no size variations of ≥3bp in mononucleotide markers in tumor tissue compared to normal tissue.

  Through study completion, an average of 1 year

Secondary Outcomes (1)

• Copy-number variations (CNVs)

  Through study completion, an average of 1 year

Other Outcomes (1)

• PD-L1 level

  Through study completion, an average of 1 year

Study Arms (2)

Early-onset colorectal cancer

Early-onset colorectal cancer

Late-onset colorectal cancer

Late-onset colorectal cancer

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

No.

You may qualify if:

• Men and women aged 18-75 years old;
• Histologically proven colon or rectal adenocarcinoma.

You may not qualify if:

• Patients over 80 years of age;
• Recurrent colorectal cancer;
• Multiple primary tumors.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

MeSH Terms

Conditions

Colorectal Neoplasms; Microsatellite Instability

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Genomic Instability; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: February 2, 2024
• Study Start: January 1, 2003
• Primary Completion: December 31, 2022
• Study Completion: January 1, 2024
• Last Updated: February 2, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share