Prostate CancerLiVHOUNCT06214000
Primary Care-Based Follow-up of Cancer Survivors of the Prostate and Kidney
An observational study of Prostate Cancer and Kidney Cancer, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
In France, the second cancer plan of 2009-2013 aimed to strengthen the role of MT by putting it back at the center of patient monitoring, in particular by asking "regional health agencies to encourage and support local experiments" which aim for better coordination between the city and the hospital. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostate Cancer, Kidney Cancer
- How many people
- 178 participants
- Where
- 1 siteFrance
- Study dates
- 20 Dec 2021to 21 Jun 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
- Adult, Older adult
Study population: Adult subjects (≥18 years old) operated on for localized prostate or kidney cancer during the period from 01/01/2015 to 12/31/2021
Who may be able to join
- Adult subjects (≥18 years old)
- Patient operated on for localized prostate or kidney cancer
- Patient followed at the HUS during the period from 01/01/2015 to 12/31/2021
- Subject who has not expressed his opposition, after information, to the reuse of his data for the purposes of this research.
Who cannot join
- Subject having expressed opposition to participating in the study
- Patient under active therapy (hormonotherapy, systemic treatment) for the pathology studied
- Impossibility of providing the subject with informed information (difficulties in understanding the subject, etc.)
- Subject under judicial protection
- Subjects under guardianship or curatorship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Primary Care-Based Follow-up of Cancer Survivors of the Prostate and Kidney: A Retrospective Study
In France, the second cancer plan of 2009-2013 aimed to strengthen the role of MT by putting it back at the center of patient monitoring, in particular by asking "regional health agencies to encourage and support local experiments" which aim for better coordination between the city and the hospital. The third cancer plan for 2014-2019 insists on this measure because it had proven to be unproductive, and recommends, in addition to the creation of a nurse dedicated to the coordination of care between community medicine and the hospital, the creation of a direct telephone line to reach the hospital medical team. This measure is mainly aimed at the follow-up of certain cancers that do not require the technical support of the hospital, as is the case in the post-operative follow-up of RCC and CaP, where the additional examinations carried out during follow-up are carried out in the city.
The research hypothesis is that this new method of monitoring had a positive impact on care in terms of quality, accessibility, organization and costs.
- Conditions
- Prostate Cancer, Kidney Cancer
- Keywords
- Prostate Cancer, kidney cancer
- Medical subject headings
- Prostatic Neoplasms, Kidney Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the economic impact of the treatment of patients operated on for localized prostate or kidney cancer
This study concerns a retrospective evaluation of the economic cost of treatment of localized prostate or kidney cancer in patients followed at the University Hospitals of Strasbourg during the period from January 1, 2015 to December 31, 2021.
Measured: The period concerned is from January 1, 2015 to December 31, 2021.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start20 Dec 2021
- Primary completion21 Jun 2022
- Study completion21 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Retrospective
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06214000
- Sponsor's protocol ID
- 8500
- Acronym
- LiVHOU
- Status last verified
- Dec 2023
- First submitted
- 11 Dec 2023
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Care-Based Follow-up of Cancer Survivors of the Prostate and Kidney: A Retrospective Study
- ClinicalTrials.gov ID
- NCT06214000
- Acronym / sponsor ID
- LiVHOU / 8500
- Conditions
- Prostate Cancer, Kidney Cancer
- Keywords
- Prostate Cancer, kidney cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 20 Dec 2021 (actual)
- Primary completion
- 21 Jun 2022 (actual)
- Study completion
- 21 Jun 2022 (actual)
- First posted
- 19 Jan 2024 (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.
In France, the second cancer plan of 2009-2013 aimed to strengthen the role of MT by putting it back at the center of patient monitoring, in particular by asking "regional health agencies to encourage and support local experiments" which aim for better coordination between the city and the hospital. The third cancer plan for 2014-2019 insists on this measure because it had proven to be unproductive, and recommends, in addition to the creation of a nurse dedicated to the coordination of care between community medicine and the hospital, the creation of a direct telephone line to reach the hospital medical team. This measure is mainly aimed at the follow-up of certain cancers that do not require the technical support of the hospital, as is the case in the post-operative follow-up of RCC and CaP, where the additional examinations carried out during follow-up are carried out in the city.
The research hypothesis is that this new method of monitoring had a positive impact on care in terms of quality, accessibility, organization and costs.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult subjects (≥18 years old) operated on for localized prostate or kidney cancer during the period from 01/01/2015 to 12/31/2021
Key inclusion criteria (4 listed)
- Adult subjects (≥18 years old)
- Patient operated on for localized prostate or kidney cancer
- Patient followed at the HUS during the period from 01/01/2015 to 12/31/2021
- Subject who has not expressed his opposition, after information, to the reuse of his data for the purposes of this research.
Key exclusion criteria (5 listed)
- Subject having expressed opposition to participating in the study
- Patient under active therapy (hormonotherapy, systemic treatment) for the pathology studied
- Impossibility of providing the subject with informed information (difficulties in understanding the subject, etc.)
- Subject under judicial protection
- Subjects under guardianship or curatorship
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
Evaluation of the economic impact of the treatment of patients operated on for localized prostate or kidney cancer
Time frame: The period concerned is from January 1, 2015 to December 31, 2021.
This study concerns a retrospective evaluation of the economic cost of treatment of localized prostate or kidney cancer in patients followed at the University Hospitals of Strasbourg during the period from January 1, 2015 to December 31, 2021.
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 13 Mar 2024.
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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 Prostate Cancer and Kidney Cancer, run by University Hospital, Strasbourg, France 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 13 Mar 2024. 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?
Evaluation of the economic impact of the treatment of patients operated on for localized prostate or kidney cancer (time frame: The period concerned is from January 1, 2015 to December 31, 2021.). 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 13 Mar 2024.