Mutations with survival and recurrence in resected liver cancer
| ISRCTN | ISRCTN16843951 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16843951 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Zhongshan Hospital |
| Funders | National Natural Science Foundation of China, Shanghai Technical Standard Program, Shanghai Medical Innovation Research Project |
- Submission date
- 15/01/2023
- Registration date
- 30/01/2023
- Last edited
- 30/01/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Intrahepatic cholangiocarcinoma (ICC) is the second most common primary liver cancer and characterized by high invasiveness and frequent postoperative recurrence. In view of high tumor recurrence, adjuvant strategies have been explored for many years. We are in urgent need of biomarkers to better select which patients are more likely to benefit from adjuvant chemotherapy.
Who can participate?
Patients with resected ICC
What does the study involve?
We enrolled patients with primary ICC from August 2014 to July 2019 who received curative resection in the Department of Liver Surgical Oncology of Zhongshan Hospital, Fudan University, Shanghai, China, and collected tissue samples from their tumors and matched non-cancerous livers. A part of each frozen sample was subjected to whole-exome sequencing. Some frozen samples and formalin-fixed, paraffin-embedded samples were used for Sanger sequencing.
What are the possible benefits and risks of participating?
This research aims to discover new biomarkers that will help to select patients who are more likely to benefit from adjuvant chemotherapy. There were no risks of participating.
Where is the study run from?
Zhongshan Hospital, Fudan University (China)
When is the study starting and how long is it expected to run for?
January 2014 to September 2022
Who is funding the study?
1. National Natural Science Foundation of China (No. 82173260, No. 81972708, No. 82072681, No. 82003082)
2. Shanghai Technical Standard Program (21DZ2201100)
3. Shanghai Medical Innovation Research Project (22Y11907300)
Who is the main contact?
Shaolai Zhou , zhoushaolai99@sina.com
Contact information
Principal investigator
Department of Liver Surgery and Transplantation
Liver Cancer Institute
Zhongshan Hospital
Fudan University
1609 Xie Tu Road
Shanghai
200032
China
 ORCID ID |
0000-0002-8526-5221 |
|---|---|
| Phone | +86 21 64041990 |
| zhoushaolai99@sina.com |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Single-centre cohort study |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | Association of IDH1 mutations with survival and recurrence in resected intrahepatic cholangiocarcinoma received or not received adjuvant chemotherapy |
| Study objectives | The presence of IDH1 mutations was associated with better survival and decreased risk of recurrence in patients with resected ICC who received adjuvant chemotherapy |
| Ethics approval(s) | Approved 06/05/2021, Research Ethics Committee of Zhongshan Hospital (Zhongshan Hospital, Fudan University, 136 Yi Xue Yuan Road, Shanghai 200032, China; +86-21-31587871; ec@zs-hospital.sh.cn), ref: B2021-305 |
| Health condition(s) or problem(s) studied | Intrahepatic cholangiocarcinoma |
| Intervention | Our research is an observation study. No intervention was involved in the course of the study. We collected tissue samples from patients attending the Department of Pathology of Zhongshan Hospital. The team enrolled patients with primary ICC who were receiving curative resection. Tissue samples were collected from the tumors and matched non-cancerous livers. All the tissues were used for whole-exome sequencing or Sanger sequencing to discover biomarkers to better select which patients are more likely to benefit from adjuvant chemotherapy. The clinical information of patients about treatment methods and survival time were collected from the clinical information database of Zhongshan Hospital. Before surgical operation and tissue sample collection, oral and written informed consent from each participant, with information such as the use of tissue sample and clinical characteristics for scientific research, which was granted by The Research Ethics Committee of Zhongshan Hospital. Patients receiving palliative surgeries, prior interventions or who have other primary malignancies and inflammatory diseases during the follow-up were excluded from the study. Patients who received chemotherapy or not received adjuvant chemotherapy after surgery. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
1. Disease-free survival (DFS), defined as the interval between the surgery and any diagnosis of recurrence, measured using data collected every 3 months in the clinical information database of Zhongshan Hospital at one timepoint |
| Key secondary outcome measure(s) |
Gene mutation measured using whole-exome sequencing or Sanger sequencing at one timepoint |
| Completion date | 30/09/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 803 |
| Total final enrolment | 803 |
| Key inclusion criteria | 1. Age >20 years old 2. Male/female 3. Primary Intrahepatic Cholangiocarcinoma in patients who received curative resection |
| Key exclusion criteria | 1. Patients receiving palliative surgeries, prior interventions or with other primary malignancies and inflammatory diseases during the follow-up were excluded from the study 2. Patients with further lymph node involvement were considered to have distant metastasis and were excluded from the study. |
| Date of first enrolment | 01/01/2021 |
| Date of final enrolment | 01/09/2022 |
Locations
Countries of recruitment
- China
Study participating centre
Shanghai
200032
China
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Published as a supplement to the results publication |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be published as a supplement to the results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
26/01/2023: Trial's existence confirmed by the National Natural Science Foundation of China.
