Development of a chart that can be used to aid prediction of hidden cancerous growths in colorectal cancer patients before surgery
| ISRCTN | ISRCTN76852032 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN76852032 |
- Submission date
- 08/03/2022
- Registration date
- 16/03/2022
- Last edited
- 01/02/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Bowel cancer is a general term for cancer that begins in the large bowel. Depending on where the cancer starts, bowel cancer is sometimes called colon or rectal cancer.
Early diagnosis of cancer spreading to the lining of the abdomen (peritoneal metastasis (PM)) is crucial to optimal treatment selection and improvement of survival, but it remains a challenge due to the high rate of missed diagnosis on computed tomography (CT) images. The aim of this study was to develop a chart for the identification of PM status in colorectal cancer (CRC) patients.
Who can participate?
Patients undergoing surgery for colorectal cancer.
What does the study involve?
Patient records of enhanced CT and laparoscopic exploration from 30/08/2007 to 26/09/2019 were analysed.
What are the possible benefits and risks of participating?
None
Where is the study run from?
The Sixth Affiliated Hospital, Sun Yat-sen University (China)
When is the study starting and how long is it expected to run for?
June 2020 to June 2021
Who is funding the study?
This study was sponsored by the National Natural Science Foundation of China (grant No. 82103084) and the Sun Yat-sen University Clinical Research 5010 Program (grant No. 2019021).
Who is the main contact?
Hui Wang, wang89@mail.sysu.edu.cn
Huaiming Wang, wanghm7@mail.sysu.edu.cn
Contact information
Principal Investigator
No.26 Yuancun Road
Tianhe District
Guangzhou
510655
China
 ORCID ID |
0000-0002-9761-7933 |
|---|---|
| Phone | +86 17665066505 |
| zhangyx295@mail2.sysu.edu.cn |
Study information
| Study design | Observational longitudinal case-control study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case-control study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not applicable (retrospective study) |
| Scientific title | Predicting preoperative occult peritoneal metastasis in colorectal cancer patients: Development and external validation of a nomogram and study of its utility |
| Study acronym | OPM |
| Study objectives | Early diagnosis of peritoneal metastasis (PM) is crucial to optimal treatment selection and improvement of prognosis, but it remains a challenge due to the high rate of missed diagnosis on computed tomography (CT) images. The aim of this study was to develop a nomogram for identification of preoperative occult PM status in colorectal cancer (CRC) patients, which can serve as a potential decision-making support tool and guide individualized care. |
| Ethics approval(s) | Approved 17/06/2020, China Research Ethics Committee (Yuancun street, Guangzhou, Guangdong 510515, China; lunli66@126.com; +44 20-38379764), ref: 2020ZSLYEC–109 |
| Health condition(s) or problem(s) studied | Predicting preoperative occult peritoneal metastasis in colorectal cancer patients |
| Intervention | All enrolled patients were initially diagnosed as PM-negative by CT readings, but later confirmed with the actual PM status during the laparoscopic exploration. The patients were divided into two cohorts: one training cohort (n = 552 from center 1) and one external validation cohort (n = 70 from center 2). All enrolled patients underwent enhanced CT examinations within two weeks before operation. The total duration of observation was from the diagnosis to the postoperative histological confirmation. The total duration of follow-up was not applicable because this study aimed to develop a risk model rather than a prognostic model. |
| Intervention type | Other |
| Primary outcome measure | The actual PM status confirmed using the intraoperative or postoperative histological evaluations at a single time point |
| Secondary outcome measures | The predictive accuracy measured using receiver operating characteristic curve and calibration curves at a single time point |
| Overall study start date | 17/06/2020 |
| Completion date | 17/06/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 500 |
| Total final enrolment | 662 |
| Key inclusion criteria | Current inclusion criteria as of 28/03/2022: 1. Patients were diagnosed with CRC by endoscopy-biopsy pathology, combined with CT and/or other examinations 2. Patients had only one malignant primary tumor 3. Patients did not undergo previous resection of the primary tumor 4. Patients underwent both enhanced CT and laparoscopic exploration Previous inclusion criteria: 1. Diagnosed CRC by endoscopy-biopsy pathology, combined with CT and/or other examination 2. With no other malignant primary tumours 3. With no previous abdominal malignancies or inflammatory diseases 4. With no previous resection of primary tumour 5. With both enhanced CT and laparoscopic exploration. |
| Key exclusion criteria | Current exclusion criteria as of 28/03/2022: 1. Typical PM signs on CT 2. Other distant metastases 3. Previous inflammatory diseases Previous exclusion criteria: 1. With typical PM signs on CT 2. With other distant metastases 3. Incomplete or missing information |
| Date of first enrolment | 30/08/2007 |
| Date of final enrolment | 26/09/2019 |
Locations
Countries of recruitment
- China
Study participating centres
Tianhe Distrcit
Guangzhou
510655
China
Haizhu Distrcit
Guangzhou
510000
China
Sponsor information
Hospital/treatment centre
No.26 Yuancun Road
Tianhe District
Guangzhou
510655
China
| Phone | +86 20-38254000 |
|---|---|
| 735212425@qq.com | |
| Website | https://www.zs6y.com |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Chinese National Science Foundation, Natural Science Foundation of China, National Science Foundation of China, NNSF of China, NSF of China, 国家自然科学基金委员会, National Nature Science Foundation of China, Guójiā Zìrán Kēxué Jījīn Wěiyuánhuì, NSFC, NNSF, NNSFC
- Location
- China
No information available
Results and Publications
| Intention to publish date | 01/01/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request. zhangyx295@mail2.sysu.edu.cn |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 13/07/2022 | 02/08/2022 | Yes | No |
Editorial Notes
01/02/2023: Internal review.
02/08/2022: Publication reference added.
28/03/2022: The inclusion and exclusion criteria were updated.
10/03/2022: Trial's existence confirmed by China Research Ethics Committee
