- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06118125
Delay to Diagnosis in Digestive Cancerology by the General Practitioner Related to Covid-19 Pandemic Confinement
November 1, 2023 updated by: Blanc-Bisson Christele, University of Bordeaux
Delay to Diagnosis and Management in Digestive Cancerology by the General Practitioner Within the City-hospital Network in the Context of Confinement Related to the Covid-19 Pandemic
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.
Study Overview
Status
Completed
Detailed 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.
Study Type
Observational
Enrollment (Actual)
376
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Bordeaux, France, 33076
- Blanc-Bisson Christele
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Male and female under 18 years old
- 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.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
2019
patients diagnosed in 2019
|
2020
patients diagnosed in 2020
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
time from date of first symptoms of cancer to the date of first MDT
Time Frame: DAYS
|
time from date of first symptoms of cancer to the date of first MDT
|
DAYS
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
time from date of first symptoms to date of first consultation with a general practitioner,
Time Frame: DAYS
|
time from date of first symptoms to date of first consultation with a general practitioner,
|
DAYS
|
time from date of first symptoms to first imaging or specific examination,
Time Frame: DAYS
|
difficulties in referral to imaging,
|
DAYS
|
time from date of first symptoms to consultation with a specialist,
Time Frame: DAYS
|
difficulties in referral to a specialist,
|
DAYS
|
stage of pathology by type of cancer,
Time Frame: at inclusion
|
stage of pathology by type of cancer according to TNM classification (tumor, node, metastatic status)
|
at inclusion
|
frequency of different types of cancer,
Time Frame: at inclusion
|
PERCENTAGE of each type of cancers in this study
|
at inclusion
|
overall survival.
Time Frame: MONTHS, time from from date of first symptoms to date of death
|
overall survival.
|
MONTHS, time from from date of first symptoms to date of death
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2019
Primary Completion (Actual)
September 1, 2022
Study Completion (Actual)
September 1, 2022
Study Registration Dates
First Submitted
October 25, 2023
First Submitted That Met QC Criteria
November 1, 2023
First Posted (Actual)
November 7, 2023
Study Record Updates
Last Update Posted (Actual)
November 7, 2023
Last Update Submitted That Met QC Criteria
November 1, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Liver Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Neoplasms
- COVID-19
- Disease
- Colorectal Neoplasms
- Liver Neoplasms
Other Study ID Numbers
- 2023-A02271-44
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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