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Gastric CancersNCT06606912

Predictive Effect of Abdominal Fat and Muscle Area Calculated Based on Abdominal CT on Gastric Cancer Patients

An observational study of Gastric Cancers and Colorectal Cancer, run by First Affiliated Hospital of Chongqing Medical University at 3 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
Gastric Cancers, Colorectal Cancer, Sarcopenia
What is being tested?
Skeletal muscle, subcutaneous fat and visceral fat area
Type of treatment
Injection or infusion
How many people
4,000 participants
Where
3 sitesChina
Study dates
1 Jan 2012to 31 Dec 2024
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 gastric and colorectal cancer and undergoing radical surgery for gastric and colorectal cancer at the study centre.

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

China3 sites

  • the First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400016

  • the Second Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400016

  • The Affiliated Yongchuan Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 402160

Other trials in China

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 Gastric 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 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.

Read the detailed description

This is a retrospective observational study, which is expected to include patients diagnosed with gastric cancer and undergoing radical gastric 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\'s Hospital, and to discuss the predictive effects of abdominal fat and muscle area on the short-term and long-term outcomes of gastric cancer patients after surgery.

  1. Case collection Patients diagnosed with gastric cancer and undergoing radical gastric cancer surgery were screened according to the inclusion criteria. All patients had signed informed consent.

Inclusion criteria:

  1. Diagnosed with gastric 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.
  6. 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; 3. Prognostic follow-up Closely follow up the death or cancer recurrence of patients after surgery. 4. Outcome indicators
  7. Primary outcome indicators: overall survival (OS), disease-free survival (DFS), postoperative complications.
  8. Secondary outcome indicators: postoperative recovery time, hospitalization time, postoperative weight change.
  9. 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.
  10. Statistical Analysis
  11. Basic characteristics and imaging indices were described as mean and standard deviation or median and standard deviation.
  12. 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.
  13. 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.).
Being tested
Skeletal muscle, subcutaneous fat and visceral fat area
Keywords
Subcutaneous Fat, Visceral fat, gastrointestinal cancer, sarcopenia, surgery
Medical subject headings
Stomach Neoplasms, Colorectal Neoplasms, Sarcopenia, Obesity, Overweight, Gastrointestinal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Skeletal muscle, subcutaneous fat and visceral fat areaOther

    Also called Sarcopenia, obesity, overweight

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    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)

  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.

  1. First posted23 Sep 2024
  2. Study start1 Jan 2012
  3. Primary completion1 Jan 2024
  4. Study completion31 Dec 2024 (estimated)

Resources

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
4,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06606912
Sponsor's protocol ID
ZZ2024-158-01
Status last verified
Sep 2024
First submitted
16 Sep 2024
Last updated
23 Sep 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36978044

  • 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.

    PubMed 34970225

  • 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.

    PubMed 21228782

Questions about this trial

What is this clinical trial studying?

An observational study of Gastric Cancers and Colorectal Cancer, 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 23 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 NCT06606912, 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 23 Sep 2024.

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