NCT06606912

Brief Summary

This study aims to create a clinical prediction model. Abdominal fat and muscle area also play an important role in the prediction of surgical outcomes in colorectal cancer. Studies have shown that excess visceral fat and low skeletal muscle mass (sarcopenia) are associated with poorer postoperative outcomes, including a higher risk of postoperative complications and lower survival. Preoperative imaging techniques such as CT, MRI and ultrasound that provide accurate measurements to assess abdominal fat and muscle area can help surgeons develop individualized surgical and rehabilitation plans, improve surgical success, reduce complications and improve long-term patient prognosis. In this study, the investigators expected to construct a prediction model of abdominal fat and muscle area on the short- and long-term outcomes of gastric and colorectal cancer patients by calculating the abdominal fat and muscle area in different levels of abdominal CT images, in order to further adjust and guide the treatment plan.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
12 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 23, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

September 23, 2024

Status Verified

September 1, 2024

Enrollment Period

12 years

First QC Date

September 16, 2024

Last Update Submit

September 19, 2024

Conditions

Keywords

Subcutaneous FatVisceral fatgastrointestinal cancersarcopeniasurgery

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    Overall survival was defined as time from date of diagnosis until the date of death from any cause or or loss to follow-up.

    From date of diagnosis until the date of death from any cause or or loss to follow-up, whichever came first, assessed up to 60 months

Secondary Outcomes (1)

  • Rate of postoperative complications

    From date of surgery until the date of first documented postoperative complication, assessed up to 2 months after surgery.

Interventions

CT-based measurement of skeletal muscle, subcutaneous fat and visceral fat areas at L1, L2, L3, L4 and L5 levels.

Also known as: Sarcopenia, obesity, overweight

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All adult patients diagnosed with gastric and colorectal cancer and undergoing radical surgery for gastric and colorectal cancer at the study centre.

You may qualify if:

  • Diagnosis of gastric cancer or colorectal cancer confirmed by pathology or cytology;
  • aged \>18 years;
  • not received chemotherapy, radiotherapy, targeted therapy or immunotherapy;
  • post-operative pathological stages other than stage IV, or no liver, lung or other organs as confirmed by CT, MRI, B-ultrasound imaging.
  • patients who have pre-operative CT examination data kept in our hospital.

You may not qualify if:

  • Poor quality of preoperative CT images;
  • refusal to participate in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

the First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

Location

the Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

Location

The Affiliated Yongchuan Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 402160, China

Location

Related Publications (3)

  • Han J, Liu X, Tang M, Yang F, Ding Z, Wu G. Abdominal fat and muscle distributions in different stages of colorectal cancer. BMC Cancer. 2023 Mar 28;23(1):279. doi: 10.1186/s12885-023-10736-2.

    PMID: 36978044BACKGROUND
  • Sun J, Lv H, Zhang M, Li M, Zhao L, Zeng N, Liu Y, Wei X, Chen Q, Ren P, Liu Y, Zhang P, Yang Z, Zhang Z, Wang Z. The Appropriateness Criteria of Abdominal Fat Measurement at the Level of the L1-L2 Intervertebral Disc in Patients With Obesity. Front Endocrinol (Lausanne). 2021 Dec 14;12:784056. doi: 10.3389/fendo.2021.784056. eCollection 2021.

    PMID: 34970225BACKGROUND
  • Koh H, Hayashi T, Sato KK, Harita N, Maeda I, Nishizawa Y, Endo G, Fujimoto WY, Boyko EJ, Hikita Y. Visceral adiposity, not abdominal subcutaneous fat area, is associated with high blood pressure in Japanese men: the Ohtori study. Hypertens Res. 2011 May;34(5):565-72. doi: 10.1038/hr.2010.271. Epub 2011 Jan 13.

    PMID: 21228782BACKGROUND

MeSH Terms

Conditions

Stomach NeoplasmsColorectal NeoplasmsSarcopeniaObesityOverweightGastrointestinal Neoplasms

Interventions

Adiposity

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesIntestinal NeoplasmsColonic DiseasesIntestinal DiseasesRectal DiseasesMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody Weight

Intervention Hierarchy (Ancestors)

Body Fat DistributionBody Weights and MeasuresBody ConstitutionPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisBody CompositionBiochemical PhenomenaChemical PhenomenaMetabolismPhysiological Phenomena

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

September 16, 2024

First Posted

September 23, 2024

Study Start

January 1, 2012

Primary Completion

January 1, 2024

Study Completion

December 31, 2024

Last Updated

September 23, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations