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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06118125
Other study ID # 2023-A02271-44
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2019
Est. completion date September 1, 2022

Study information

Verified date November 2023
Source University of Bordeaux
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Objective: the pre-hospital management of cancers is little known in General Medicine. The first lockdown related to the COVID-19 pandemic led to the closure of health facilities. Investigators were interested in the diagnosis and care pathway of digestive cancers in post-confinement in General Medicine in Nouvelle-Aquitaine.


Description:

Method: patient records discussed in Digestive Oncology CPR of Bordeaux University Hospital for the first time from June 1 to August 31, 2020 and over the same period in 2019 were included. A questionnaire on the dates of the first symptoms, first consultation with the general practitioner, imaging examination and access to the specialist was sent to the general practitioner. The primary outcome was time from onset to date of first MDT.


Recruitment information / eligibility

Status Completed
Enrollment 376
Est. completion date September 1, 2022
Est. primary completion date September 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - residing in New Aquitaine and - whose general practitioner practiced in New Aquitaine - malignant tumors of the esophagus, stomach, small intestine, colon, recto-sigmoid junction, rectum, anus and anal canal, liver and intrahepatic bile ducts, extrahepatic bile ducts, gallbladder and pancreas. - to have had at least one consultation or hospitalization in the digestive pole of the Bordeaux University Hospital within 6 months after the MDT. Exclusion Criteria: - Patients under 18 years of age, - who had already had a MDT for this cancer, - whose date of first MDT was outside the inclusion dates, - whose new cancer was a digestive metastasis of a primary of another location, - who did not have French health insurance

Study Design


Locations

Country Name City State
France Blanc-Bisson Christele Bordeaux

Sponsors (1)

Lead Sponsor Collaborator
University of Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary time from date of first symptoms of cancer to the date of first MDT time from date of first symptoms of cancer to the date of first MDT DAYS
Secondary time from date of first symptoms to date of first consultation with a general practitioner, time from date of first symptoms to date of first consultation with a general practitioner, DAYS
Secondary time from date of first symptoms to first imaging or specific examination, difficulties in referral to imaging, DAYS
Secondary time from date of first symptoms to consultation with a specialist, difficulties in referral to a specialist, DAYS
Secondary stage of pathology by type of cancer, stage of pathology by type of cancer according to TNM classification (tumor, node, metastatic status) at inclusion
Secondary frequency of different types of cancer, PERCENTAGE of each type of cancers in this study at inclusion
Secondary overall survival. overall survival. MONTHS, time from from date of first symptoms to date of death
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