ClinicalTrials.gg
Status unknownNCT06443086Updated Jun 5, 2024

Long-term Outcomes of Duodenal Adenocarcinoma From a Large Cohort

An observational study in Gastrointestinal Disease, sponsored by Nanfang Hospital, Southern Medical University. Status unknown. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-06-05.

Sponsored by Nanfang Hospital, Southern Medical University · Observational

The sponsor has not verified this record recently (last verified Jun 2024), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
400
Ages
18 Years to 80 Years
Sex
All
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Study 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 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.

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Conditions studied

  • Gastrointestinal Disease
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In context

Gastrointestinal Diseases

639 studies on the registry are indexed under Gastrointestinal Diseases; 126 are open to participants now.

This study's planned enrollment of 400 is above the median of 350 across 195 observational studies indexed under Gastrointestinal Diseases.

Browse Gastrointestinal Diseases studies →

Lead sponsor

Nanfang Hospital, Southern Medical University is the lead sponsor of 488 studies on the registry; 213 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

(1) histologically confirmed non-ampulla DA;

Exclusion criteria

Exclusion criteria:

  1. had other gastrointestinal cancer;
  2. had incomplete medical records, or lost follow-up shortly after diagnosis;
  3. refused clinical data collection.
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
400 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

    Procedure: Radical operation and perioperative therapy

Interventions

  • ProcedureRadical operation and perioperative therapy

    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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 2009.10-2023.06

  2. 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

    Time frame: 2009.10-2023.06

  3. 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

    Time frame: 2009.10-2023.06

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Study locations

No study locations are listed for this record.

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References and documents

Study documents

  • Protocol and statistical analysis plan · Apr 2, 2024
  • Informed consent form · Apr 2, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06443086
Responsible party
Sponsor
First posted
Jun 5, 2024
Start date
Jun 15, 2024 (estimated)
Primary completion
Dec 30, 2024 (estimated)
Completion
Dec 30, 2024 (estimated)
Last update
Jun 5, 2024

Study contacts

Hao Liu, MD, PhD
Contact
hao.liu@alumni.uni-heidelberg.de
+86-20-62787626
Hao Liu, MD, PhD
principal investigator · Department of General Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, China

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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