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Evaluation of Salivary RNAs in the Presence of an Adnexal Mass of Ovarian Origin (OVAmiARN)

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ClinicalTrials.gov Identifier: NCT05514028
Recruitment Status : Recruiting
First Posted : August 24, 2022
Last Update Posted : April 10, 2024
Sponsor:
Collaborators:
Monitoring Force Group
iGenSeq
Information provided by (Responsible Party):
ZIWIG

Study Description
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Brief 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

Condition or disease Intervention/treatment
Ovarian Cancer Ovarian Cyst Benign Borderline Ovarian Cancer Other: Salivary samples

Study Design
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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Salivary RNAs in the Presence of an Adnexal Mass of Ovarian Origin - OVAmiARN Study
Actual Study Start Date : May 4, 2022
Estimated Primary Completion Date : April 2026
Estimated Study Completion Date : April 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Groups and Cohorts
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Group/Cohort Intervention/treatment
Cyst Benign
100 patients
 Other: 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
 Other: 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
 Other: 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)


Outcome Measures
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Primary Outcome Measures :
  1. Area under the curve (AUC) of the Receiver Operating Curve (ROC) [ Time Frame: Through the end of study inclusions, an average of 6 months ]
    Identifying a signature of ovarian cancer diagnosis by analysis of coding and non-coding RNAs in the saliva of subjects


Biospecimen Retention:   Samples Without DNA
Saliva

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05514028


Locations
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France
CHU de Caen Recruiting
Caen, Calvados, France, 14000
Contact: Raffaèle Fauvet, Pr    02 31 27 23 36    fauvet-r@chu-caen.fr   
Principal Investigator: Raffaèle Fauvet, Pr         
CHU Angers Recruiting
Angers, France, 49933
Contact: Philippe Descamps, Pr    +33 2 41 35 48 99    phdescamps@chu-angers.fr   
Principal Investigator: Philippe Descamps, Pr         
CH Bastia Recruiting
Bastia, France, 20600
Contact: Laetitia Elisabeth Rocca, Dr    +33495591111    laetitia-elisabeth.rocca@ch-bastia.fr   
Principal Investigator: Laetitia Elisabeth Rocca, Dr         
CHU Lyon Sud / Hospices Civils de Lyon Recruiting
Lyon, France, 69000
Contact: François Golfier, Pr    04 78 86 41 78    françois.golfier@chu-lyon.fr   
Principal Investigator: François Golfier, Pr         
Sub-Investigator: Mathieu Poilblanc, Dr         
Centre Antoine Lacassagne Recruiting
Nice, France
Contact: Marie Gosset, MD    04 92 03 13 35    Marie.GOSSET@nice.unicancer.fr   
CH Niort Recruiting
Niort, France, 79021
Contact: Sandrine Richard, Dr    05 49 78 25 90    sandrine.richard@ch-niort.fr   
Principal Investigator: Sandrine Richard, Dr         
CHU Tenon Recruiting
Paris, France, 75020
Contact: Sofiane Bendifallah, Dr    01 56 01 68 31    sofiane.bendifallah@yahoo.fr   
Sub-Investigator: Cyril Touboul, Pr         
Principal Investigator: Emile Darai, Pr         
Sub-Investigator: Sofiane Bendifallah, Dr         
CHU Rennes Recruiting
Rennes, France, 35000
Contact: Vincent Lavoué, Pr    02 99 26 71 21    vincent.lavoue@chu-rennes.fr   
Principal Investigator: Vinvent Lavoué, Pr         
Clinique La sagesse Recruiting
Rennes, France
Contact: Claire Marie Roger, MD    02 99 85 75 14    cmroger@lasagesse.fr   
CHU Rouen, Hôpital de Bois-Guillaume Recruiting
Rouen, France
Contact: Clotilde Hennetier, MD    02 32 88 89 90    Clotilde.hennetier@chu-rouen.fr   
Clinique Pasteur Recruiting
Toulouse, France
Contact: Ludivine Genre, MD    05 62 21 36 30    lgenre@clinique-pasteur.com   
CHRU Bretonneau-Tours Recruiting
Tours, France, 37044
Contact: Lobna Ouldamer, Pr    02 47 47 47 41    l.ouldamer@chu-tours.fr   
Principal Investigator: Lobna Ouldamer         
Sponsors and Collaborators
ZIWIG
Monitoring Force Group
iGenSeq
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: ZIWIG
ClinicalTrials.gov Identifier: NCT05514028    
Other Study ID Numbers: FR-22-01
First Posted: August 24, 2022    Key Record Dates
Last Update Posted: April 10, 2024
Last Verified: April 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ZIWIG:
Cancer
RNA
machine learning algorithms
Ovarian
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Ovarian Cysts
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
 Urogenital Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Genital Diseases
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Cysts