Evaluation of Salivary RNAs in the Presence of an Adnexal Mass of Ovarian Origin
NCT ID: NCT05514028
Last Updated: 2024-04-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
250 participants
OBSERVATIONAL
2022-05-04
2026-04-30
Brief Summary
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The study population consists of patients with an ovarian adnexal mass diagnosed by clinical examination and imaging (pelvic ultrasound and/or MRI) and requiring surgical management in routine care.
The patients concerned by the study will be managed without modification of the care pathway, nor modification of the therapeutic indications, nor modification of the diagnostic or follow-up examinations (imaging or biology) necessary according to the context, which are carried out according to the recommendations of the HAS, CNGOF.
In this study, the management and follow-up of patients :
* Are not imposed by the study: the doctor remains free to make medical prescriptions (treatments and examinations) and to determine the interval between consultation visits,
* Are not modified in comparison with the usual follow-up, except for the performance of the Collection of saliva
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cyst Benign
100 patients
Salivary samples
For patients with a benign ovarian cyst, 1 saliva sample taken at 3 times (concomitant with a visit performed in routine care):
* During the inclusion visit,
* At the postoperative visit,
* At the 6-month follow-up visit
For patients with ovarian cancer, 1 saliva sample taken at different times (concomitant with a visit performed in routine care):
* At the inclusion visit,
* During the postoperative visit,
* At the follow-up visits (6 months post-surgery and then every 6 months until 24 months)
For patients with a borderline ovarian tumor, 1 saliva sample taken at different times (concomitant with a visit performed in routine care):
* At the inclusion visit,
* During the postoperative visit,
* During pre- and post-chemotherapy visits (before and after each cycle)
* During follow-up visits (every 4 months until 24 months)
Ovarian Cancer
120 patients
Salivary samples
For patients with a benign ovarian cyst, 1 saliva sample taken at 3 times (concomitant with a visit performed in routine care):
* During the inclusion visit,
* At the postoperative visit,
* At the 6-month follow-up visit
For patients with ovarian cancer, 1 saliva sample taken at different times (concomitant with a visit performed in routine care):
* At the inclusion visit,
* During the postoperative visit,
* At the follow-up visits (6 months post-surgery and then every 6 months until 24 months)
For patients with a borderline ovarian tumor, 1 saliva sample taken at different times (concomitant with a visit performed in routine care):
* At the inclusion visit,
* During the postoperative visit,
* During pre- and post-chemotherapy visits (before and after each cycle)
* During follow-up visits (every 4 months until 24 months)
Borderline Ovarian Cancer
30 patients
Salivary samples
For patients with a benign ovarian cyst, 1 saliva sample taken at 3 times (concomitant with a visit performed in routine care):
* During the inclusion visit,
* At the postoperative visit,
* At the 6-month follow-up visit
For patients with ovarian cancer, 1 saliva sample taken at different times (concomitant with a visit performed in routine care):
* At the inclusion visit,
* During the postoperative visit,
* At the follow-up visits (6 months post-surgery and then every 6 months until 24 months)
For patients with a borderline ovarian tumor, 1 saliva sample taken at different times (concomitant with a visit performed in routine care):
* At the inclusion visit,
* During the postoperative visit,
* During pre- and post-chemotherapy visits (before and after each cycle)
* During follow-up visits (every 4 months until 24 months)
Interventions
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Salivary samples
For patients with a benign ovarian cyst, 1 saliva sample taken at 3 times (concomitant with a visit performed in routine care):
* During the inclusion visit,
* At the postoperative visit,
* At the 6-month follow-up visit
For patients with ovarian cancer, 1 saliva sample taken at different times (concomitant with a visit performed in routine care):
* At the inclusion visit,
* During the postoperative visit,
* At the follow-up visits (6 months post-surgery and then every 6 months until 24 months)
For patients with a borderline ovarian tumor, 1 saliva sample taken at different times (concomitant with a visit performed in routine care):
* At the inclusion visit,
* During the postoperative visit,
* During pre- and post-chemotherapy visits (before and after each cycle)
* During follow-up visits (every 4 months until 24 months)
Eligibility Criteria
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Inclusion Criteria
* A patient with an ovarian adnexal mass diagnosed by clinical examination and imaging and likely to be ovarian cancer, a borderline tumour or a benign cyst,
* Patient with an indication for surgery
* Patient has dated and signed the consent form,
* Patient affiliated to the healthcare system,
Exclusion Criteria
* Patient infected with human immunodeficiency virus (HIV),
* Patient with significant difficulties in reading or writing the French language.
* Patient with another diagnosed cancer
* Patient with a history of cancer less than 5 years old
18 Years
FEMALE
No
Sponsors
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Monitoring Force Group
INDUSTRY
iGenSeq
UNKNOWN
ZIWIG
INDUSTRY
Responsible Party
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Locations
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CHU de Caen
Caen, Calvados, France
CHU Angers
Angers, , France
CH Bastia
Bastia, , France
CHU Lyon Sud / Hospices Civils de Lyon
Lyon, , France
Centre Antoine Lacassagne
Nice, , France
CH Niort
Niort, , France
CHU Tenon
Paris, , France
CHU Rennes
Rennes, , France
Clinique La sagesse
Rennes, , France
CHU Rouen, Hôpital de Bois-Guillaume
Rouen, , France
Clinique Pasteur
Toulouse, , France
CHRU Bretonneau-Tours
Tours, , France
Countries
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Facility Contacts
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Other Identifiers
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FR-22-01
Identifier Type: -
Identifier Source: org_study_id
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