ChemeotherapyCOVIDICANCT04389684
Clinical and Psycho-social Impact of COVID-19 Related Confinement on Patients With Digestive Tumors
An observational study of Chemeotherapy and Immunotherapy, run by Poitiers University Hospital at 3 sites in France.
Trial summary
To limit Corona virus dissemination on its territory, France applied strict confinement from March 16th to May 11th. Scientific societies recommended treatment modifications and remote consultations that were applied. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemeotherapy, Immunotherapy, Treatment Mofidied
- What is being tested?
- Psycho-Social Questionnaire
- How many people
- 102 participants
- Where
- 3 sitesFrance
- Study dates
- 27 May 2020to 20 Nov 2020
- 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: Patients under chemotherapy, immunotherapy or targeted therapy for a digestive tumor had their treatment modified during Coronavirus epidemia in France.
Who may be able to join
- Histologically proven digestive tumor
- Ongoing treatment from March,1st and April 30th
Who cannot join
- Patient refusal for enrollment in the study
- Patient not recognised legally competent
Trial locations and contacts
3 sites in 1 country.
France3 sites
MOULIN Valérie
La Rochelle
BOURGEOIS Hugues
Le Mans
RANDRIAN Violaine
Poitiers
About this study
Official title: Clinical and Psycho-Social Impact on Patients With Digestive Tumors of Treatment and Care Modifications Linked to COVID-19 in France
To limit Corona virus dissemination on its territory, France applied strict confinement from March 16th to May 11th. Scientific societies recommended treatment modifications and remote consultations that were applied. This study evaluates the clinical impact of these care adaptation on patients under treatment for a digestive tumor. A special focus is made on quality of life and psycho-social impact of treatment modifications on patients diagnosed with metastatic colorectal cancer and metastatic pancreatic cancer.
- Conditions
- Chemeotherapy, Immunotherapy, Treatment Mofidied, Coronavirus, Quality of Life
- Being tested
- Psycho-Social Questionnaire
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psycho-Social QuestionnaireOther
Patients, after enrollmenet in the study, receive a paper questionnaire during the month following COVID19 related confinement and all the material to send it back to the institution. They receive the same questionnaire 3 months later with all the material to send it back to the institution. The intervention is the same for all patients wether their treatment was modified or not.
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival of patients with metastatic colorectal cancer or metastatic pancreatic cancer
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2020
- Study start27 May 2020
- Primary completion20 Nov 2020
- Study completion20 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ChemeotherapyStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04389684
- Sponsor's protocol ID
- 2020-A01301-38
- Acronym
- COVIDICA
- Status last verified
- Nov 2021
- First submitted
- 14 May 2020
- Last updated
- 29 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Randrian V, Dhimene A, Pillet A, Evrard C, Elfadel R, Boyer C, Guyot d'Asnieres de Salins A, Ingrand I, Ferru A, Rouleau L, Tougeron D. COVID-19 lockdown-related treatment modifications did not impact the outcome of digestive cancers: the Clin-COVIDICA prospective study. BMC Cancer. 2025 Mar 5;25(1):398. doi: 10.1186/s12885-025-13787-9.
PubMed 40045328
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Psycho-Social Impact on Patients With Digestive Tumors of Treatment and Care Modifications Linked to COVID-19 in France
- ClinicalTrials.gov ID
- NCT04389684
- Acronym / sponsor ID
- COVIDICA / 2020-A01301-38
- Conditions
- Chemeotherapy, Immunotherapy, Treatment Mofidied, Coronavirus, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 27 May 2020 (actual)
- Primary completion
- 20 Nov 2020 (actual)
- Study completion
- 20 Nov 2020 (actual)
- First posted
- 15 May 2020 (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.
To limit Corona virus dissemination on its territory, France applied strict confinement from March 16th to May 11th. Scientific societies recommended treatment modifications and remote consultations that were applied. This study evaluates the clinical impact of these care adaptation on patients under treatment for a digestive tumor. A special focus is made on quality of life and psycho-social impact of treatment modifications on patients diagnosed with metastatic colorectal cancer and metastatic pancreatic cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients under chemotherapy, immunotherapy or targeted therapy for a digestive tumor had their treatment modified during Coronavirus epidemia in France.
Key inclusion criteria (2 listed)
- Histologically proven digestive tumor
- Ongoing treatment from March,1st and April 30th
Key exclusion criteria (2 listed)
- Patient refusal for enrollment in the study
- Patient not recognised legally competent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psycho-Social QuestionnairePatients, after enrollmenet in the study, receive a paper questionnaire during the month following COVID19 related confinement and all the material to send it back to the institution. They receive the same questionnaire 3 months later with all the material to send it back to the institution. The intervention is the same for all patients wether their treatment was modified or not. | Other | – |
Primary outcome
Overall survival of patients with metastatic colorectal cancer or metastatic pancreatic cancer
Time frame: 6 months
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 29 Nov 2021.
- Derived from this study: PubMed 40045328Randrian V, Dhimene A, Pillet A, Evrard C, Elfadel R, Boyer C, Guyot d'Asnieres de Salins A, Ingrand I, Ferru A, Rouleau L, Tougeron D. COVID-19 lockdown-related treatment modifications did not impact the outcome of digestive cancers: the Clin-COVIDICA prospective study. BMC Cancer. 2025 Mar 5;25(1):398. doi: 10.1186/s12885-025-13787-9.
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chemeotherapy and Immunotherapy, run by Poitiers University Hospital at 3 sites 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 2 inclusion and 2 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 29 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Overall survival of patients with metastatic colorectal cancer or metastatic pancreatic cancer (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04389684, which also lists 1 linked publication.
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 29 Nov 2021.