Gastrointestinal DiseaseNCT06443086
Long-term Outcomes of Duodenal Adenocarcinoma From a Large Cohort
An observational study of Gastrointestinal Disease, run by Nanfang Hospital, Southern Medical University.
Trial summary
The investigators will conducted a hospital-based cohort study in our 15-year experience with DA aimed at investigating the long-term outcomes of the patients with DA, along with analyzing the impact of the tumor characteristics, operations and adjuvant therapy on survival outcomes. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastrointestinal Disease
- What is being tested?
- Radical operation and perioperative therapy
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2024to 30 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients included in this study were drawn from a hospital-based cohort and included cases diagnosed and treated at the facility. Inclusion criteria were histologically confirmed non-ampulla DA, including all stages of disease at diagnosis. Patients were excluded if they had ampulla cancer or other forms of gastrointestinal cancer, had incomplete medical records, or lost follow-up shortly after diagnosis. This rigorous selection process ensured the homogeneity of the study population and the relevance of the findings to non-ampulla DA.
Who may be able to join
- histologically confirmed non-ampulla DA;
Who cannot join
- had other gastrointestinal cancer;
- had incomplete medical records, or lost follow-up shortly after diagnosis;
- refused clinical data collection.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Long-term Survival Outcomes of Duodenal Adenocarcinoma: a Cohort Study With 15-year Single-center Experience
The investigators will conducted a hospital-based cohort study in our 15-year experience with DA aimed at investigating the long-term outcomes of the patients with DA, along with analyzing the impact of the tumor characteristics, operations and adjuvant therapy on survival outcomes.
Read the detailed description
Numerous meta-analyses and systematic reviews have delved into the treatment of DA, yet the majority of the studies retrospective, single-center, and small sample size series, particularly in China. To bridge this knowledge gap, the investigators will conduct a hospital-based cohort study designed to investigate the long-term survival outcomes of the participants with the non-ampulla duodenal adenocarcinoma, and the effects of tumor characteristics, surgery, and adjuvant therapy on survival outcomes.
- Conditions
- Gastrointestinal Disease
- Being tested
- Radical operation and perioperative therapy
- Medical subject headings
- Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radical operation and perioperative therapyProcedure or surgery
Surgical intervention, particularly radical excision, was performed for each patient, including the extent of resection and lymph node dissection. Information on adjuvant therapies, such as chemotherapy and radiotherapy, was also recorded, specifying the regimens and durations.
| Study group | Role | What they receive |
|---|---|---|
| Duodenal carcinoma patients | The patients included in this study were drawn from a hospital-based cohort and included cases diagnosed and treated at the facility. Inclusion criteria were histologically confirmed non-ampulla DA, including all stages of disease at diagnosis. Patients were excluded if they had ampulla cancer or other forms of gastrointestinal cancer, had incomplete medical records, or lost follow-up shortly after diagnosis. This rigorous selection process ensured the homogeneity of the study population and the relevance of the findings to non-ampulla DA. Receives: Procedure: Radical operation and perioperative therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median overall survival time
Median survival is the time it takes half of the individuals in a given study population to reach or exceed a particular end event, calculated from the time an event occurred. Median survival is a statistical index describing the distribution of survival time.
Measured: 2009.10-2023.06
3-year overall survival rate
Three-year survival rate, also known as survival rate, refers to the number of patients with a disease who are still alive at the end of three years of follow-up as a percentage of the number of cases observed
Measured: 2009.10-2023.06
5-year overall survival rate
Five-year survival rate, also known as survival rate, refers to the number of patients with a disease who are still alive at the end of five years of follow-up as a percentage of the number of cases observed
Measured: 2009.10-2023.06
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
- Study start15 Jun 2024 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal DiseaseStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hao Liu, MD, PhD, Principal investigator, Department of General Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06443086
- Sponsor's protocol ID
- NFEC-2024-171
- Status last verified
- Jun 2024
- First submitted
- 28 May 2024
- Last updated
- 5 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Survival Outcomes of Duodenal Adenocarcinoma: a Cohort Study With 15-year Single-center Experience
- ClinicalTrials.gov ID
- NCT06443086
- Acronym / sponsor ID
- NFEC-2024-171
- Conditions
- Gastrointestinal Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 15 Jun 2024 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 5 Jun 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.
The investigators will conducted a hospital-based cohort study in our 15-year experience with DA aimed at investigating the long-term outcomes of the patients with DA, along with analyzing the impact of the tumor characteristics, operations and adjuvant therapy on survival outcomes.
Detailed description
Numerous meta-analyses and systematic reviews have delved into the treatment of DA, yet the majority of the studies retrospective, single-center, and small sample size series, particularly in China. To bridge this knowledge gap, the investigators will conduct a hospital-based cohort study designed to investigate the long-term survival outcomes of the participants with the non-ampulla duodenal adenocarcinoma, and the effects of tumor characteristics, surgery, and adjuvant therapy on survival outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Duodenal carcinoma patients | – | Procedure: Radical operation and perioperative therapyThe patients included in this study were drawn from a hospital-based cohort and included cases diagnosed and treated at the facility. Inclusion criteria were histologically confirmed non-ampulla DA, including all stages of disease at diagnosis. Patients were excluded if they had ampulla cancer or other forms of gastrointestinal cancer, had incomplete medical records, or lost follow-up shortly after diagnosis. This rigorous selection process ensured the homogeneity of the study population and the relevance of the findings to non-ampulla DA. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients included in this study were drawn from a hospital-based cohort and included cases diagnosed and treated at the facility. Inclusion criteria were histologically confirmed non-ampulla DA, including all stages of disease at diagnosis. Patients were excluded if they had ampulla cancer or other forms of gastrointestinal cancer, had incomplete medical records, or lost follow-up shortly after diagnosis. This rigorous selection process ensured the homogeneity of the study population and the relevance of the findings to non-ampulla DA.
Key inclusion criteria (1 listed)
- histologically confirmed non-ampulla DA;
Key exclusion criteria (3 listed)
- had other gastrointestinal cancer;
- had incomplete medical records, or lost follow-up shortly after diagnosis;
- refused clinical data collection.
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 |
|---|---|---|
| Radical operation and perioperative therapySurgical intervention, particularly radical excision, was performed for each patient, including the extent of resection and lymph node dissection. Information on adjuvant therapies, such as chemotherapy and radiotherapy, was also recorded, specifying the regimens and durations. | Procedure or surgery | Duodenal carcinoma patients |
Primary outcome
Median overall survival time
Time frame: 2009.10-2023.06
Median survival is the time it takes half of the individuals in a given study population to reach or exceed a particular end event, calculated from the time an event occurred. Median survival is a statistical index describing the distribution of survival time.
3-year overall survival rate
Time frame: 2009.10-2023.06
Three-year survival rate, also known as survival rate, refers to the number of patients with a disease who are still alive at the end of three years of follow-up as a percentage of the number of cases observed
5-year overall survival rate
Time frame: 2009.10-2023.06
Five-year survival rate, also known as survival rate, refers to the number of patients with a disease who are still alive at the end of five years of follow-up as a percentage of the number of cases observed
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2024.
- Individual participant dataSharing planned: Undecided
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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.
Hao Liu, MD, PhD principal investigator
Department of General Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, China
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Disease, run by Nanfang Hospital, Southern Medical University.
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 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 5 Jun 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hao Liu, MD, PhD (+86-20-62787626, hao.liu@alumni.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median overall survival time (time frame: 2009.10-2023.06). The study lists 3 primary outcomes in all. 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 5 Jun 2024.