Trial Title:
Evaluation of Salivary RNAs in the Presence of an Adnexal Mass of Ovarian Origin
NCT ID:
NCT05514028
Condition:
Ovarian Cancer
Ovarian Cyst Benign
Borderline Ovarian Cancer
Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Ovarian Cysts
Conditions: Keywords:
Cancer
RNA
machine learning algorithms
Ovarian
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Salivary samples
Description:
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)
Arm group label:
Borderline Ovarian Cancer
Arm group label:
Cyst Benign
Arm group label:
Ovarian Cancer
Summary:
OVAmiARN is a multicentre, prospective, longitudinal, non-interventional, observational
study carried out in 8 obstetrics and gynecology departments in France; in order to
describe the evolution of salivary miRNA expression between the pre-operative and
post-therapy visits according to the type of mass. In time, the clinical application will
be to significantly reduce the time to diagnosis and improve the care pathway for ovarian
adnexal mass.
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
Criteria for eligibility:
Study pop:
The study population consists of patients with an ovarian adnexal mass diagnosed by
clinical examination and imaging (pelvic ultrasound and/or MRI and/or blood tumour
markers) and requiring surgical management in routine care.
The patients concerned by the study already benefit from a surgical management in
different gynecology-obstetrics/gynecological oncology departments in France, Canada and
Tunisia, as well as from a validation of the therapeutic indications in accordance with
the national practices in force.
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 and/or blood tumour markers) necessary
according to the context which are carried out according to the national and/or
international recommendations in force.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Patient over 18 years of age,
- 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:
- Pregnant patient
- 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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
CHU de Caen
Address:
City:
Caen
Zip:
14000
Country:
France
Status:
Recruiting
Contact:
Last name:
Raffaèle Fauvet, Pr
Phone:
02 31 27 23 36
Email:
fauvet-r@chu-caen.fr
Investigator:
Last name:
Raffaèle Fauvet, Pr
Email:
Principal Investigator
Facility:
Name:
CHU Angers
Address:
City:
Angers
Zip:
49933
Country:
France
Status:
Recruiting
Contact:
Last name:
Philippe Descamps, Pr
Phone:
+33 2 41 35 48 99
Email:
phdescamps@chu-angers.fr
Investigator:
Last name:
Philippe Descamps, Pr
Email:
Principal Investigator
Facility:
Name:
CH Bastia
Address:
City:
Bastia
Zip:
20600
Country:
France
Status:
Recruiting
Contact:
Last name:
Laetitia Elisabeth Rocca, Dr
Phone:
+33495591111
Email:
laetitia-elisabeth.rocca@ch-bastia.fr
Investigator:
Last name:
Laetitia Elisabeth Rocca, Dr
Email:
Principal Investigator
Facility:
Name:
CHU Lyon Sud / Hospices Civils de Lyon
Address:
City:
Lyon
Zip:
69000
Country:
France
Status:
Recruiting
Contact:
Last name:
François Golfier, Pr
Phone:
04 78 86 41 78
Email:
françois.golfier@chu-lyon.fr
Investigator:
Last name:
François Golfier, Pr
Email:
Principal Investigator
Investigator:
Last name:
Mathieu Poilblanc, Dr
Email:
Sub-Investigator
Facility:
Name:
Centre Antoine Lacassagne
Address:
City:
Nice
Country:
France
Status:
Recruiting
Contact:
Last name:
Marie Gosset, MD
Phone:
04 92 03 13 35
Email:
Marie.GOSSET@nice.unicancer.fr
Facility:
Name:
CH Niort
Address:
City:
Niort
Zip:
79021
Country:
France
Status:
Recruiting
Contact:
Last name:
Sandrine Richard, Dr
Phone:
05 49 78 25 90
Email:
sandrine.richard@ch-niort.fr
Investigator:
Last name:
Sandrine Richard, Dr
Email:
Principal Investigator
Facility:
Name:
CHU Tenon
Address:
City:
Paris
Zip:
75020
Country:
France
Status:
Recruiting
Contact:
Last name:
Sofiane Bendifallah, Dr
Phone:
01 56 01 68 31
Email:
sofiane.bendifallah@yahoo.fr
Investigator:
Last name:
Cyril Touboul, Pr
Email:
Sub-Investigator
Investigator:
Last name:
Emile Darai, Pr
Email:
Principal Investigator
Investigator:
Last name:
Sofiane Bendifallah, Dr
Email:
Sub-Investigator
Facility:
Name:
CHU Rennes
Address:
City:
Rennes
Zip:
35000
Country:
France
Status:
Recruiting
Contact:
Last name:
Vincent Lavoué, Pr
Phone:
02 99 26 71 21
Email:
vincent.lavoue@chu-rennes.fr
Investigator:
Last name:
Vinvent Lavoué, Pr
Email:
Principal Investigator
Facility:
Name:
Clinique La sagesse
Address:
City:
Rennes
Country:
France
Status:
Recruiting
Contact:
Last name:
Claire Marie Roger, MD
Phone:
02 99 85 75 14
Email:
cmroger@lasagesse.fr
Facility:
Name:
CHU Rouen, Hôpital de Bois-Guillaume
Address:
City:
Rouen
Country:
France
Status:
Recruiting
Contact:
Last name:
Clotilde Hennetier, MD
Phone:
02 32 88 89 90
Email:
Clotilde.hennetier@chu-rouen.fr
Facility:
Name:
Clinique Pasteur
Address:
City:
Toulouse
Country:
France
Status:
Recruiting
Contact:
Last name:
Ludivine Genre, MD
Phone:
05 62 21 36 30
Email:
lgenre@clinique-pasteur.com
Facility:
Name:
CHRU Bretonneau-Tours
Address:
City:
Tours
Zip:
37044
Country:
France
Status:
Recruiting
Contact:
Last name:
Lobna Ouldamer, Pr
Phone:
02 47 47 47 41
Email:
l.ouldamer@chu-tours.fr
Investigator:
Last name:
Lobna Ouldamer
Email:
Principal Investigator
Start date:
May 4, 2022
Completion date:
April 2026
Lead sponsor:
Agency:
ZIWIG
Agency class:
Industry
Collaborator:
Agency:
Monitoring Force Group
Agency class:
Industry
Collaborator:
Agency:
iGenSeq
Agency class:
Other
Source:
ZIWIG
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05514028
