NCT06614699

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 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
8,000

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 24, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 26, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

September 27, 2024

Status Verified

September 1, 2024

Enrollment Period

12 years

First QC Date

September 24, 2024

Last Update Submit

September 26, 2024

Conditions

Keywords

Subcutaneous FatVisceral fatColorectal 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.

Study Arms (1)

the colorectal cancer group

Abdominal fat and muscle area were calculated based on abdominal CT of colorectal cancer patients.

Other: abdominal fat and muscle area

Interventions

Abdominal fat and muscle area were calculated based on abdominal CT.

the colorectal cancer group

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 colorectal cancer and undergoing radical surgery for colorectal cancer at the study centre.

You may qualify if:

  • , Diagnosis of 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 Affiliated Yongchuan Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400000, China

Location

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400000, China

Location

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

Location

Related Publications (3)

  • Sahin MEH, Akbas F, Yardimci AH, Sahin E. The effect of sarcopenia and sarcopenic obesity on survival in gastric cancer. BMC Cancer. 2023 Sep 28;23(1):911. doi: 10.1186/s12885-023-11423-y.

    PMID: 37770828BACKGROUND
  • Arulananda S, Segelov E. Sarcopenia and cancer-related inflammation measurements in advanced gastric and junctional cancers-ready for prime time? Ann Oncol. 2022 Jul;33(7):669-671. doi: 10.1016/j.annonc.2022.04.008. Epub 2022 Apr 14. No abstract available.

    PMID: 35430371BACKGROUND
  • Xia L, Zhao R, Wan Q, Wu Y, Zhou Y, Wang Y, Cui Y, Shen X, Wu X. Sarcopenia and adverse health-related outcomes: An umbrella review of meta-analyses of observational studies. Cancer Med. 2020 Nov;9(21):7964-7978. doi: 10.1002/cam4.3428. Epub 2020 Sep 13.

    PMID: 32924316BACKGROUND

MeSH Terms

Conditions

Colorectal NeoplasmsSarcopeniaObesityOverweight

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody Weight

Study Officials

  • Dong Peng, Ph.D.

    First Affiliated Hospital of Chongqing Medical University

    PRINCIPAL INVESTIGATOR

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 24, 2024

First Posted

September 26, 2024

Study Start

January 1, 2012

Primary Completion

January 1, 2024

Study Completion

June 1, 2025

Last Updated

September 27, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

IPD is not allowed sharing in this three clinic centers.

Locations