Changes in Body Composition of Patients With Obesity Related Tumors and Their Impact on Clinical Outcomes: a Multicenter Prospective Cohort Study

Not yet recruiting

• Conditions: Obesity Rekated Cancer; Survival; Body Composition Changes; Mechanism

• Registration Number: NCT07161167
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

Over the past 20 years, China's obesity rates have surged, increasing cancer burden. Obesity links to 13 cancers via metabolic effects of visceral fat and insulin resistance, while sarcopenic obesity (BMI-independent) may worsen outcomes. Traditional BMI lacks precision; advanced methods (e.g., BIA/CT) are needed. Existing studies show inconsistent results, possibly due to heterogeneity. This multicenter prospective cohort study uses imaging to assess body composition changes (fat/muscle) in obesity-related tumors and their impact on survival, recurrence, and quality of life, and explore the underlying mechanism.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-21
• Study First Submitted QC: 2025-09-03
• Last Update Submitted: 2025-09-03
• Study First Posted: 2025-09-08
• Last Update Posted: 2025-09-08
• Study Start: 2025-09-15
• Primary Completion: 2030-09-30
• Study Completion: 2030-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 6743

Inclusion Criteria

1. Age ≥18 years, regardless of gender.
2. Histologically or cytologically confirmed obesity-associated malignant tumors (e.g., breast cancer, colorectal cancer, gastric cancer, lung cancer, or thyroid cancer) with planned treatment after diagnosis (any treatment modality permitted).
3. No prior chemotherapy, radiotherapy, biologic therapy, immunotherapy, or other antitumor treatments for malignancy.

Exclusion Criteria

1. Patients with concurrent non-obesity-related malignancies.
2. History of prior malignancy (except completely cured carcinoma in situ of the cervix, basal cell carcinoma, or squamous cell carcinoma of the skin).
3. Patients with concurrent multiorgan dysfunction syndrome, autoimmune diseases, infectious diseases, neurological disorders, or psychiatric disorders.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival	From date of diagnosis until the date of death from any cause, assessed up to 10 years	The time from the start of follow-up to death (for any reason).

Secondary Outcome Measures

Name	Time	Method
Progression-free survival after diagnosis	From date of diagnosis until the date of first documented progression , assessed up to 10 years
Time of recurrence and/or distant metastasis after diagnosis	From date of diagnosis until the date of first documented recurrence and/or distant metastasis, whichever came first, assessed up to 10 years

Trial Locations

Locations (1)

Peking union medical college hospital; 🇨🇳 Beijing, Beijing Municipality, China