Colorectal CancerNCT06614699
Predictive Effect of Abdominal Fat and Muscle Area Calculated Based on Abdominal CT on Colorectal Cancer Patients
An observational study of Colorectal Cancer and Sarcopenia, run by First Affiliated Hospital of Chongqing Medical University at 3 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Sarcopenia, Obesity and Overweight
- What is being tested?
- abdominal fat and muscle area
- How many people
- 8,000 participants
- Where
- 3 sitesChina
- Study dates
- 1 Jan 2012to 1 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients diagnosed with colorectal cancer and undergoing radical surgery for colorectal cancer at the study centre.
Who may be able to join
- 1, Diagnosis of colorectal cancer confirmed by pathology or cytology;
- 2, aged \>18 years;
- 3, not received chemotherapy, radiotherapy, targeted therapy or immunotherapy;
- 4, post-operative pathological stages other than stage IV, or no liver, lung or other organs as confirmed by CT, MRI, B-ultrasound imaging.
- 5, patients who have pre-operative CT examination data kept in our hospital.
Who cannot join
- 1, Poor quality of preoperative CT images;
- 2, refusal to participate in this study.
Trial locations and contacts
3 sites in 1 country.
China3 sites
The Affiliated Yongchuan Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400000
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400000
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
About this study
Official title: Predictive Effect of Abdominal Fat and Muscle Area Calculated Based on Abdominal CT on Short- and Long-term Outcomes in Patients with Colorectal Cancer
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.
Read the detailed description
This is a retrospective observational study, which is expected to include patients diagnosed with colorectal cancer and undergoing radical colorectal cancer surgery in the Department of Gastrointestinal Surgery of the First Affiliated Hospital of Chongqing Medical University, the Department of Gastrointestinal Surgery of the Second Affiliated Hospital of Chongqing Medical University, the Department of Gastrointestinal Surgery of the Affiliated Yongchuan Hospital of Chongqing Medical University, and the Department of Gastrointestinal Surgery of the Qijiang People Hospital, and to discuss the predictive effects of abdominal fat and muscle area on the short-term and long-term outcomes of colorectal cancer patients after surgery.
- Case collection Patients diagnosed with colorectal cancer and undergoing radical colorectal cancer surgery were screened according to the inclusion criteria. All patients had signed informed consent. Inclusion criteria: (1) Diagnosed with colorectal cancer by pathology or cytology; (2) Age \>18 years; (3) Not having received chemotherapy, radiotherapy, targeted therapy or immunotherapy; (4) Patients with postoperative pathological stages other than stage IV, or without metastases in liver, lung or other distant organs confirmed by CT, MRI or B-ultrasound imaging and without surgical treatment; (5) Pre-operative CT examination data were kept in our hospital.
- Data collection Collect patients' preoperative baseline information such as gender, age, body mass index (BMI), complications, tumor stage, etc. Collect patients' preoperative CT scans (make sure to include images from lumbar 1 to lumbar 5). Collect patients' surgical conditions such as operation time and intraoperative bleeding. Collect patients' postoperative complications during hospitalization;
- Prognostic follow-up Closely follow up the death or cancer recurrence of patients after surgery.
- Outcome indicators (1) Primary outcome indicators: overall survival (OS), disease-free survival (DFS), postoperative complications. (2) Secondary outcome indicators: postoperative recovery time, hospitalization time, postoperative weight change.
- Image processing 3D Slicer was used to outline the range of subcutaneous fat, visceral fat, and muscle at the level of waist 1 to waist 5 on enhanced CT (5.0mm) images. Export the segmentation result as gpj.format, and select the Area Reading Calculator to calculate the area of fat and muscle at each level. Calculate fat area and muscle area at each level, calculate overall abdominal fat area and muscle area, and use the ratio of fat area to muscle area (e.g., visceral fat/skeletal muscle) as a predictor to generate the desired quantitative analyses.
- Statistical Analysis (1) Basic characteristics and imaging indices were described as mean and standard deviation or median and standard deviation. (2) Univariate analysis including Kaplan-Meier survival analysis and Log-rank test were used to evaluate the effects of fat and muscle area on postoperative survival and complications. (3) Multivariate analysis including Cox regression models or Logistic regression models were used to evaluate the independent predictive role of abdominal fat and muscle area on surgical outcomes, controlling for potential confounders (e.g., age, gender, BMI, tumor stage, etc.).
- Conditions
- Colorectal Cancer, Sarcopenia, Obesity and Overweight
- Being tested
- abdominal fat and muscle area
- Keywords
- Subcutaneous Fat, Visceral fat, Colorectal cancer, Sarcopenia, Surgery
- Medical subject headings
- Colorectal Neoplasms, Sarcopenia, Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
abdominal fat and muscle areaOther
Abdominal fat and muscle area were calculated based on abdominal CT.
| Study group | Role | What they receive |
|---|---|---|
| the colorectal cancer group | Abdominal fat and muscle area were calculated based on abdominal CT of colorectal cancer patients. Receives: Other: abdominal fat and muscle area |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Surgical complications was defined as any postoperative complication occurring during the postoperative hospitalisation period.
Measured: From date of surgery until the date of first documented postoperative complication, assessed up to 2 months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start1 Jan 2012
- Primary completion1 Jan 2024
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Chongqing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 8,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- The Second Affiliated Hospital of Chongqing Medical University, Chongqing Medical University
- Responsible party
- Principal investigator, Dong Peng, First Affiliated Hospital of Chongqing Medical University
- Investigators
- Dong Peng, Ph.D., Principal investigator, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06614699
- Sponsor's protocol ID
- ZZ2024-158-02
- Status last verified
- Sep 2024
- First submitted
- 24 Sep 2024
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD is not allowed sharing in this three clinic centers.
Publications
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.
PubMed 37770828Arulananda 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.
PubMed 35430371Xia 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.
PubMed 32924316
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Effect of Abdominal Fat and Muscle Area Calculated Based on Abdominal CT on Short- and Long-term Outcomes in Patients with Colorectal Cancer
- ClinicalTrials.gov ID
- NCT06614699
- Acronym / sponsor ID
- ZZ2024-158-02
- Conditions
- Colorectal Cancer, Sarcopenia, Obesity and Overweight
- Keywords
- Subcutaneous Fat, Visceral fat, Colorectal cancer, Sarcopenia, Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 8,000 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Collaborators
- The Second Affiliated Hospital of Chongqing Medical University, Chongqing Medical University
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 26 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a retrospective observational study, which is expected to include patients diagnosed with colorectal cancer and undergoing radical colorectal cancer surgery in the Department of Gastrointestinal Surgery of the First Affiliated Hospital of Chongqing Medical University, the Department of Gastrointestinal Surgery of the Second Affiliated Hospital of Chongqing Medical University, the Department of Gastrointestinal Surgery of the Affiliated Yongchuan Hospital of Chongqing Medical University, and the Department of Gastrointestinal Surgery of the Qijiang People Hospital, and to discuss the predictive effects of abdominal fat and muscle area on the short-term and long-term outcomes of colorectal cancer patients after surgery.
- Case collection Patients diagnosed with colorectal cancer and undergoing radical colorectal cancer surgery were screened according to the inclusion criteria. All patients had signed informed consent. Inclusion criteria: (1) Diagnosed with colorectal cancer by pathology or cytology; (2) Age \>18 years; (3) Not having received chemotherapy, radiotherapy, targeted therapy or immunotherapy; (4) Patients with postoperative pathological stages other than stage IV, or without metastases in liver, lung or other distant organs confirmed by CT, MRI or B-ultrasound imaging and without surgical treatment; (5) Pre-operative CT examination data were kept in our hospital.
- Data collection Collect patients' preoperative baseline information such as gender, age, body mass index (BMI), complications, tumor stage, etc. Collect patients' preoperative CT scans (make sure to include images from lumbar 1 to lumbar 5). Collect patients' surgical conditions such as operation time and intraoperative bleeding. Collect patients' postoperative complications during hospitalization;
- Prognostic follow-up Closely follow up the death or cancer recurrence of patients after surgery.
- Outcome indicators (1) Primary outcome indicators: overall survival (OS), disease-free survival (DFS), postoperative complications. (2) Secondary outcome indicators: postoperative recovery time, hospitalization time, postoperative weight change.
- Image processing 3D Slicer was used to outline the range of subcutaneous fat, visceral fat, and muscle at the level of waist 1 to waist 5 on enhanced CT (5.0mm) images. Export the segmentation result as gpj.format, and select the Area Reading Calculator to calculate the area of fat and muscle at each level. Calculate fat area and muscle area at each level, calculate overall abdominal fat area and muscle area, and use the ratio of fat area to muscle area (e.g., visceral fat/skeletal muscle) as a predictor to generate the desired quantitative analyses.
- Statistical Analysis (1) Basic characteristics and imaging indices were described as mean and standard deviation or median and standard deviation. (2) Univariate analysis including Kaplan-Meier survival analysis and Log-rank test were used to evaluate the effects of fat and muscle area on postoperative survival and complications. (3) Multivariate analysis including Cox regression models or Logistic regression models were used to evaluate the independent predictive role of abdominal fat and muscle area on surgical outcomes, controlling for potential confounders (e.g., age, gender, BMI, tumor stage, etc.).
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| the colorectal cancer group | – | Other: abdominal fat and muscle areaAbdominal fat and muscle area were calculated based on abdominal CT of colorectal cancer patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients diagnosed with colorectal cancer and undergoing radical surgery for colorectal cancer at the study centre.
Key inclusion criteria (5 listed)
- 1, Diagnosis of colorectal cancer confirmed by pathology or cytology;
- 2, aged \>18 years;
- 3, not received chemotherapy, radiotherapy, targeted therapy or immunotherapy;
- 4, post-operative pathological stages other than stage IV, or no liver, lung or other organs as confirmed by CT, MRI, B-ultrasound imaging.
- 5, patients who have pre-operative CT examination data kept in our hospital.
Key exclusion criteria (2 listed)
- 1, Poor quality of preoperative CT images;
- 2, refusal to participate in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| abdominal fat and muscle areaAbdominal fat and muscle area were calculated based on abdominal CT. | Other | the colorectal cancer group |
Primary outcome
Overall survival
Time frame: 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.
Overall survival was defined as time from date of diagnosis until the date of death from any cause or or loss to follow-up.
1 secondary outcome
Rate of postoperative complications
Time frame: From date of surgery until the date of first documented postoperative complication, assessed up to 2 months after surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- Background: PubMed 37770828Sahin 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.
- Background: PubMed 35430371Arulananda 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.
- Background: PubMed 32924316Xia 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.
- Individual participant dataSharing planned: No. IPD is not allowed sharing in this three clinic centers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dong Peng, Ph.D. principal investigator
First Affiliated Hospital of Chongqing Medical University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Sarcopenia, run by First Affiliated Hospital of Chongqing Medical University at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06614699, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2024.