Epithelial Ovarian CancerVIVROVAIRE 2NCT02323568
Live After an Epithelial Ovarian Cancer: Multidisciplinary Assessment of Effects and Long-term Remission in Patients Needs.
A study testing Gynecological consultation in people with Epithelial Ovarian Cancer, run by Centre Francois Baclesse at 18 sites in France.
Trial summary
This project is part of a large multicenter multidisciplinary program that will thoroughly explore the needs and difficulties of patients with BCR as well as those involved in their care. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Epithelial Ovarian Cancer
- What is being tested?
- Gynecological consultation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 179 participants
- Where
- 18 sitesFrance
- Study dates
- Dec 2014to Jul 2016
- Phase
- Interventional
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age> 18 years;
- Patients who received optimal treatment (surgery, chemotherapy ...)
- Patients with epithelial ovarian cancer after first-line treatment;
- Patients without other cancer (except basal cell skin carcinoma and breast cancer in situ);
- Patients without clinical relapse, biological or radiological documented at least 3 years after the initial treatment (from the end date of first line chemotherapy);
- The interviews treatments are not recognized in the period;
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- Patients may be included regardless of the stage of cancer at diagnosis (early or late)
- Patients who have signed their written consent to participate in the part 2 of the study Vivrovaire;
- Patients who participated in part 1 of Vivrovaire study.
Who cannot join
- Psychiatric pathology can disrupt the conduct of the study or to prevent the interpretation of results;
- Persons deprived of liberty;
- Major subject to a measure of legal protection or unable to consent.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
France18 sites
CHU
Besançon, 25030
Institut Bergonie
Bordeaux, 33076
Polyclinique Bordeaux Nord
Bordeaux, 33077
CHU
Caen, 14033
Centre François Baclesse
Caen, 14076
Centre Hospitalier
Cholet
CHU Grenoble
La Tronche, 38700
Centre Oscar Lambret
Lille, 59020
Centre Léon Bérard
Lyon, 69008
Institut régional du cancer
Montpellier, 34298
Centre Antoine Lacassagne
Nice, 06189
Hôpital Cochin
Paris, 75014
Hôpital Européen Georges Pompidou
Paris, 75015
Institut Jean Godinot
Reims, 51100
Institut de Cancérologie de l'Ouest
Saint-Herblain, 44805
GHPSO
Senlis, 60309
Institut de cancérologie de Lorraine
Vandœuvre-lès-Nancy, 54519
Institut Gustave Roussy
Villejuif, 94805
About this study
This project is part of a large multicenter multidisciplinary program that will thoroughly explore the needs and difficulties of patients with BCR as well as those involved in their care. The results of this research program will propose recommendations for better structure and understand the follow up of these patients.
From the limited data in the literature, the long-term remission in patients with ovarian cancer reported a significant and persistent fatigue, poor QoL, disorders of sexuality as well as somatic and mental illness; consumption is also a medical records for these patients.
Read more
In this context, our team has initiated a large case-control study to assess fatigue (identified major problem in the long-term remission in patients with ovarian cancer), QoL and rehabilitation of patients in remission from an epithelial ovarian cancer (regardless of the stage of cancer at diagnosis, early or advanced) 3 years after the initial treatment, compared with women of the same age without ovarian cancer or serious chronic disease , from the general population.
Patients and controls complement standardized and validated self-administered questionnaire (part 1). This study investigated 215 patients in long remission from ovarian cancer compared to 215 women of the same age without cancer. Recruitment of patients is currently underway, in close collaboration with teams from the Group GINECO very involved in this project.
Following this step, an additional component is planned: it is to offer patients who participated in part 1, a specific gynecological consultation to assess in detail the effects of the treatments in order to better meet the needs of patients .dropoff window
- Conditions
- Epithelial Ovarian Cancer
- Being tested
- Gynecological consultation
- Keywords
- ovarian cancer, quality of life, remission more than 3 years
- Medical subject headings
- Carcinoma, Ovarian Epithelial, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gynecological consultationOther
| Study group | Role | What they receive |
|---|---|---|
| Gynecological consulation | Other | Not described Receives: Other: Gynecological consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical sequelae measured by the functional and biological effects
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epithelial Ovarian CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse
- Sponsor type
- University, hospital or other
- Collaborators
- Ligue contre le cancer, France, Fondation de France
- Responsible party
- Sponsor
- Investigators
- Florence JOLY, PhD, Principal investigator, Centre François Baclesse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02323568
- Sponsor's protocol ID
- VIVROVAIRE 2
- Acronym
- VIVROVAIRE 2
- Status last verified
- Sep 2015
- First submitted
- 11 Dec 2014
- Last updated
- 10 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Live After an Epithelial Ovarian Cancer: Multidisciplinary Assessment of Effects and Long-term Remission in Patients Needs.
- ClinicalTrials.gov ID
- NCT02323568
- Acronym / sponsor ID
- VIVROVAIRE 2 / VIVROVAIRE 2
- Conditions
- Epithelial Ovarian Cancer
- Keywords
- ovarian cancer, quality of life, remission more than 3 years
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Collaborators
- Ligue contre le cancer, France, Fondation de France
- Study start
- Dec 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 23 Dec 2014 (estimated)
- 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.
This project is part of a large multicenter multidisciplinary program that will thoroughly explore the needs and difficulties of patients with BCR as well as those involved in their care. The results of this research program will propose recommendations for better structure and understand the follow up of these patients.
From the limited data in the literature, the long-term remission in patients with ovarian cancer reported a significant and persistent fatigue, poor QoL, disorders of sexuality as well as somatic and mental illness; consumption is also a medical records for these patients.
In this context, our team has initiated a large case-control study to assess fatigue (identified major problem in the long-term remission in patients with ovarian cancer), QoL and rehabilitation of patients in remission from an epithelial ovarian cancer (regardless of the stage of cancer at diagnosis, early or advanced) 3 years after the initial treatment, compared with women of the same age without ovarian cancer or serious chronic disease , from the general population.
Patients and controls complement standardized and validated self-administered questionnaire (part 1). This study investigated 215 patients in long remission from ovarian cancer compared to 215 women of the same age without cancer. Recruitment of patients is currently underway, in close collaboration with teams from the Group GINECO very involved in this project.
Following this step, an additional component is planned: it is to offer patients who participated in part 1, a specific gynecological consultation to assess in detail the effects of the treatments in order to better meet the needs of patients .dropoff window
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gynecological consulation | Other | Other: Gynecological consultation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age> 18 years;
- Patients who received optimal treatment (surgery, chemotherapy ...)
- Patients with epithelial ovarian cancer after first-line treatment;
- Patients without other cancer (except basal cell skin carcinoma and breast cancer in situ);
- Patients without clinical relapse, biological or radiological documented at least 3 years after the initial treatment (from the end date of first line chemotherapy);
Key exclusion criteria (3 listed)
- Psychiatric pathology can disrupt the conduct of the study or to prevent the interpretation of results;
- Persons deprived of liberty;
- Major subject to a measure of legal protection or unable to consent.
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 |
|---|---|---|
| Gynecological consultation | Other | Gynecological consulation |
Primary outcome
Physical sequelae measured by the functional and biological effects
Time frame: At inclusion
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 10 Feb 2017.
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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.
Florence JOLY, PhD principal investigator
Centre François Baclesse
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gynecological consultation in people with Epithelial Ovarian Cancer, run by Centre Francois Baclesse at 18 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 9 inclusion and 3 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 10 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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?
Physical sequelae measured by the functional and biological effects (time frame: At inclusion). 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 10 Feb 2017.