Distal CholangiocarcinomaNCT06671431
Role of Adjuvant Chemotherapy in Distal Cholangiocarcinoma
An observational study of Distal Cholangiocarcinoma and Adjuvant Chemotherapy, run by Seoul National University Hospital.
Trial summary
Recent studies addressing the role of adjuvant chemotherapy in cholangiocarcinoma (CCA) have been published; however, there are challenges in generalizing the findings due to different prognostic characteristics depending on tumor location and resectability. Read more about this study
- Who is it for?
- Ages 19 to 90 years
- Conditions the study is for
- Distal Cholangiocarcinoma, Adjuvant Chemotherapy
- What is being tested?
- Adjuvant chemotherapy
- How many people
- 578 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2000to 1 Oct 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 19 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with distal cholangiocarcinoma who underwent curative surgery
Who may be able to join
- Patients with distal cholangiocarcinoma who underwent surgery
Who cannot join
- Who underwent neoadjuvant treatment
- Who underwent R2 resection
- Non-adenocarcinoma patients in final pathology report
- Insufficient data
- Death within 90days of surgery
About this study
Official title: Role of Adjuvant Chemotherapy in Distal Cholangiocarcinoma: a Retrospective Cohort Study
Recent studies addressing the role of adjuvant chemotherapy in cholangiocarcinoma (CCA) have been published; however, there are challenges in generalizing the findings due to different prognostic characteristics depending on tumor location and resectability. Therefore, the aim of this study was to investigate the role of AC in distal cholangiocarcinoma, a common tumor subtype of CCA.
- Conditions
- Distal Cholangiocarcinoma, Adjuvant Chemotherapy
- Being tested
- Adjuvant chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjuvant chemotherapyDrug
Adjuvant chemotherapy with or without radiotherapy
What is being measured
The primary outcome is the main question the study is designed to answer.
Role of Adjuvant Chemotherapy in Distal Cholangiocarcinoma
Measured: From January 2000 to December 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start1 Jan 2000
- Primary completion31 Dec 2021
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal CholangiocarcinomaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 578 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06671431
- Sponsor's protocol ID
- 2408-168-1565
- Status last verified
- Oct 2024
- First submitted
- 31 Oct 2024
- Last updated
- 4 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Adjuvant Chemotherapy in Distal Cholangiocarcinoma: a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT06671431
- Acronym / sponsor ID
- 2408-168-1565
- Conditions
- Distal Cholangiocarcinoma, Adjuvant Chemotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 578 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2000 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 4 Nov 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.
Recent studies addressing the role of adjuvant chemotherapy in cholangiocarcinoma (CCA) have been published; however, there are challenges in generalizing the findings due to different prognostic characteristics depending on tumor location and resectability. Therefore, the aim of this study was to investigate the role of AC in distal cholangiocarcinoma, a common tumor subtype of CCA.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 19 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with distal cholangiocarcinoma who underwent curative surgery
Key inclusion criteria (1 listed)
- Patients with distal cholangiocarcinoma who underwent surgery
Key exclusion criteria (5 listed)
- Who underwent neoadjuvant treatment
- Who underwent R2 resection
- Non-adenocarcinoma patients in final pathology report
- Insufficient data
- Death within 90days of surgery
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 |
|---|---|---|
| Adjuvant chemotherapyAdjuvant chemotherapy with or without radiotherapy | Drug | – |
Primary outcome
Role of Adjuvant Chemotherapy in Distal Cholangiocarcinoma
Time frame: From January 2000 to December 2021
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
Related trials for Distal Cholangiocarcinoma
Active, not recruitingPhase 2
Study of Chemotherapy, With or Without Binimetinib in Advanced Biliary Tract Cancers in 2nd Line Setting (A ComboMATCH Treatment Trial)
Advanced Biliary Tract Carcinoma, Advanced Gallbladder Carcinoma
Active, not recruitingPhase 3
Rilvegostomig + Chemotherapy as Adjuvant Therapy for Biliary Tract Cancer After Resection (ARTEMIDE-Biliary01)
Biliary Tract Cancer
RecruitingPhase 2
Alternating Chemo-immunotherapy and FGFR Inhibitor for FGFR-positive Biliary or Cholangiocarcinoma
Locally Advanced Ampulla of Vater Carcinoma, Locally Advanced Biliary Tract Carcinoma
Not yet recruitingPhase 1
GI-06: The Impact of Perioperative Hydrocortisone on Patients Undergoing Partial Pancreatectomy
Pancreatic Cancer, Pancreatic Adenocarcinoma
RecruitingPhase 2/3
Neoadjuvant Gemcitabine and Cisplatin in Combination With Perioperative Pembrolizumab Versus Upfront Surgery for Patients With Primary Resectable and Borderline Resectable Perihilar and Distal Cholangiocarcinoma
Extrahepatic Cholangiocarcinoma, Perihilar Cholangiocarcinoma
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Distal Cholangiocarcinoma and Adjuvant Chemotherapy, run by Seoul National University Hospital.
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 1 inclusion and 5 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: finished, as of the sponsor's last update on 4 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Role of Adjuvant Chemotherapy in Distal Cholangiocarcinoma (time frame: From January 2000 to December 2021). 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 4 Nov 2024.