Neoplasms, ColorectalNCT06118125
Delay to Diagnosis in Digestive Cancerology by the General Practitioner Related to Covid-19 Pandemic Confinement
An observational study of Neoplasms, Colorectal and General Practitioner, run by University of Bordeaux at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms, Colorectal, General Practitioner, Pandemic, COVID-19
- How many people
- 376 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2019to 1 Sep 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Neoplasms, Colorectal, General Practitioner, Pandemic, COVID-19, Neoplasm, Liver, Neoplasms Pancreatic, Diagnosis
- Keywords
- digestive cancer, covid
- Medical subject headings
- Colorectal Neoplasms, COVID-19, Liver Neoplasms, Pancreatic Neoplasms, Disease, Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 2019 | patients diagnosed in 2019 | |
| 2020 | patients diagnosed in 2020 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: DAYS
Secondary outcomes (6)
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,
Measured: DAYS
time from date of first symptoms to first imaging or specific examination,
difficulties in referral to imaging,
Measured: DAYS
time from date of first symptoms to consultation with a specialist,
difficulties in referral to a specialist,
Measured: DAYS
stage of pathology by type of cancer,
stage of pathology by type of cancer according to TNM classification (tumor, node, metastatic status)
Measured: at inclusion
frequency of different types of cancer,
PERCENTAGE of each type of cancers in this study
Measured: at inclusion
overall survival.
overall survival.
Measured: MONTHS, time from from date of first symptoms to date of death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start1 Jun 2019
- Primary completion1 Sep 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasms, ColorectalStudies of the same condition, open and under way.
- 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
- 376 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Blanc-Bisson Christele, University of Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06118125
- Sponsor's protocol ID
- 2023-A02271-44
- Status last verified
- Nov 2023
- First submitted
- 25 Oct 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06118125
- Acronym / sponsor ID
- 2023-A02271-44
- Conditions
- Neoplasms, Colorectal, General Practitioner, Pandemic, COVID-19, Neoplasm, Liver, Neoplasms Pancreatic, Diagnosis
- Keywords
- digestive cancer, covid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 376 participants (actual)
- Lead sponsor
- University of BordeauxUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 7 Nov 2023 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2019 | – | –patients diagnosed in 2019 |
| 2020 | – | –patients diagnosed in 2020 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
6 secondary outcomes
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 first imaging or specific examination,
Time frame: DAYS
time from date of first symptoms to consultation with a specialist,
Time frame: DAYS
stage of pathology by type of cancer,
Time frame: at inclusion
frequency of different types of cancer,
Time frame: at inclusion
overall survival.
Time frame: MONTHS, time from from date of first symptoms to date of death
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Individual participant dataSharing planned: No
Related trials for Neoplasms, Colorectal
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neoplasms, Colorectal and General Practitioner, run by University of Bordeaux at 1 site in France.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time from date of first symptoms of cancer to the date of first MDT (time frame: DAYS). 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 7 Nov 2023.