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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06443086
Other study ID # NFEC-2024-171
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 15, 2024
Est. completion date December 30, 2024

Study information

Verified date June 2024
Source Nanfang Hospital, Southern Medical University
Contact Hao Liu, MD, PhD
Phone +86-20-62787626
Email hao.liu@alumni.uni-heidelberg.de
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 400
Est. completion date December 30, 2024
Est. primary completion date December 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion criteria: (1) histologically confirmed non-ampulla DA; Exclusion criteria: 1. had other gastrointestinal cancer; 2. had incomplete medical records, or lost follow-up shortly after diagnosis; 3. refused clinical data collection.

Study Design


Intervention

Procedure:
Radical 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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Nanfang Hospital, Southern Medical University

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 2009.10-2023.06
Primary 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 2009.10-2023.06
Primary 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 2009.10-2023.06
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