Hilar CholangiocarcinomaNCT05626127
MRI-based Clinico-radiomics Predicting Lymph Node Metastasis Status of Hilar Cholangiocarcinoma
An observational study of Hilar Cholangiocarcinoma, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
This is a prospective, observational diagnostic study aiming to assess multiparametric MRI-based clinico-radiomics for identifying lymph node metastasis status in hilar cholangiocarcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hilar Cholangiocarcinoma
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 20 Nov 2022to 1 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who had resectable hilar cholangiocarcinoma and completed the upper abdomen MRI examination before surgery.
Who may be able to join
- The patient must sign an informed consent form;
- Age 18-75 years old, both male and female;
- ECOG performance status score (PS score) 0-2;
- Hilar cholangiocarcinoma with resectable tumor lesions;
- Complete the upper abdomen MRI examination before treatment;
Who cannot join
- Accompanied with other primary malignant tumors;
- Patients who have neoadjuvant chemotherapy or other tumor-targeted therapies;
- Incomplete imaging or medical history data.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510220
Honghua Zhang, PhD, 020-34078840, zhanghh68@mail.sysu.edu.cn
About this study
Official title: Evaluation of a MRI-based Clinico-radiomics Model in Predicting Lymph Node Metastasis Status of Hilar Cholangiocarcinoma Patients: a Prospective Diagnostic Study
This is a prospective, observational diagnostic study aiming to assess multiparametric MRI-based clinico-radiomics for identifying lymph node metastasis status in hilar cholangiocarcinoma.
Read the detailed description
A preoperative tool capable of predicting lymph node metastasis status in hilar cholangiocarcinoma is lacking and urgently needed for clinical practice. This study proposes to establish and evaluate a machine-learning algorithms of multiparametric MRI-based clinico-radiomics for identifying lymph node metastasis status in hilar cholangiocarcinoma. This study will investigate the relationship between radiomic depth information and tumor biological characteristics. The study includes the construction of capable MRI-based clinico-radiomics prediction model and the validation of the prediction model.
- Conditions
- Hilar Cholangiocarcinoma
- Being tested
- No interventions
- Keywords
- Hilar Cholangiocarcinoma, Lymph Node Metastasis, Radiomics, Machine-learning, Prognosis
- Medical subject headings
- Klatskin Tumor, Lymphatic Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionsOther
As this is a observational study, there are no interventions.
| Study group | Role | What they receive |
|---|---|---|
| Sun Yat-Sen Memorial Hospital of Sun Yat-sen University | The cohort of Sun Yat-Sen Memorial Hospital of Sun Yat-sen University is the validation cohort. Receives: Other: No interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lymph node metastasis status
The value of multiparametric MRI-based clinico-radiomics in predicting lymph node metastasis.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2022
- Study start20 Nov 2022 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hilar CholangiocarcinomaStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chao Liu, PhD, Principal investigator, Department of Biliary and Pancreatic Surgery, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05626127
- Sponsor's protocol ID
- SYSKY-2022-267-01
- Status last verified
- Nov 2022
- First submitted
- 16 Nov 2022
- Last updated
- 23 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a MRI-based Clinico-radiomics Model in Predicting Lymph Node Metastasis Status of Hilar Cholangiocarcinoma Patients: a Prospective Diagnostic Study
- ClinicalTrials.gov ID
- NCT05626127
- Acronym / sponsor ID
- SYSKY-2022-267-01
- Conditions
- Hilar Cholangiocarcinoma
- Keywords
- Hilar Cholangiocarcinoma, Lymph Node Metastasis, Radiomics, Machine-learning, Prognosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 20 Nov 2022 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 23 Nov 2022 (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 is a prospective, observational diagnostic study aiming to assess multiparametric MRI-based clinico-radiomics for identifying lymph node metastasis status in hilar cholangiocarcinoma.
Detailed description
A preoperative tool capable of predicting lymph node metastasis status in hilar cholangiocarcinoma is lacking and urgently needed for clinical practice. This study proposes to establish and evaluate a machine-learning algorithms of multiparametric MRI-based clinico-radiomics for identifying lymph node metastasis status in hilar cholangiocarcinoma. This study will investigate the relationship between radiomic depth information and tumor biological characteristics. The study includes the construction of capable MRI-based clinico-radiomics prediction model and the validation of the prediction model.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sun Yat-Sen Memorial Hospital of Sun Yat-sen University | – | Other: No interventionsThe cohort of Sun Yat-Sen Memorial Hospital of Sun Yat-sen University is the validation cohort. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who had resectable hilar cholangiocarcinoma and completed the upper abdomen MRI examination before surgery.
Key inclusion criteria (5 listed)
- The patient must sign an informed consent form;
- Age 18-75 years old, both male and female;
- ECOG performance status score (PS score) 0-2;
- Hilar cholangiocarcinoma with resectable tumor lesions;
- Complete the upper abdomen MRI examination before treatment;
Key exclusion criteria (3 listed)
- Accompanied with other primary malignant tumors;
- Patients who have neoadjuvant chemotherapy or other tumor-targeted therapies;
- Incomplete imaging or medical history data.
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 |
|---|---|---|
| No interventionsAs this is a observational study, there are no interventions. | Other | Sun Yat-Sen Memorial Hospital of Sun Yat-sen University |
Primary outcome
Lymph node metastasis status
Time frame: Baseline
The value of multiparametric MRI-based clinico-radiomics in predicting lymph node metastasis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2022.
- Individual participant dataSharing planned: No
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Rilvegostomig + Chemotherapy as Adjuvant Therapy for Biliary Tract Cancer After Resection (ARTEMIDE-Biliary01)
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Phase II Study of Neoadjuvant Tislelizumab Plus Radiotherapy and GP Chemotherapy for Borderline/Unresectable Hilar Cholangiocarcinoma
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Suprapapillary Metal Stent vs. Routine Transpapillary Drainage in Malignant Hilar Biliary Obstruction (SMART-B Trial)
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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.
Chao Liu, PhD principal investigator
Department of Biliary and Pancreatic Surgery, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hilar Cholangiocarcinoma, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site 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 3 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 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Honghua Zhang, PhD (020-34078840, zhanghh68@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lymph node metastasis status (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Nov 2022.