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Circulating Tumor DNA as an Early Marker of Recurrence and Treatment Efficacy in Ovarian Carcinoma (CIDOC)

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ClinicalTrials.gov Identifier: NCT03302884
Recruitment Status : Not yet recruiting
First Posted : October 5, 2017
Last Update Posted : December 7, 2017
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Institut Paoli-Calmettes

Brief Summary:
Prospective multicentre assay to assess ctDNA value for ovarian cancer monitoring and disease recurrence after front-line treatment.

Condition or disease Intervention/treatment Phase
Ovarian Carcinoma Other: biological sampling Not Applicable

Detailed Description:

The main objective is to explore the capacity of ctDNA to be an early marker of ovarian carcinoma recurrence after front-line treatments, i.e. to show significant modifications before clinical diagnosis of disease relapse.

Prospective multicentre open-label study

During visits in the frame of management of the disease, blood samples will be collected at diagnosis, after each cycle of eventual neoadjuvant chemotherapy, every 6 months during the following 2 years, and every year during the remainin time of follow-up. Tumor samples will be collected at surgery or through a biopsy.

Patients will then have a standard care follow-up for a period of 5 years.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Circulating Tumor DNA as an Early Marker of Recurrence and Treatment Efficacy in Ovarian Carcinoma
Estimated Study Start Date : December 30, 2017
Estimated Primary Completion Date : October 30, 2022
Estimated Study Completion Date : October 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arm Intervention/treatment
Experimental: Biological sampling in ovarian carcinoma
Blood and tumor samples
Other: biological sampling
Tumor and blood samples




Primary Outcome Measures :
  1. Prognostic value of ctDNA increase for predicting a subsequent clinical, radiological (RECIST v1.1) or biological (CA-125 according to GCIG criteria) diagnosis of disease relapse. [ Time Frame: at diagnosis, after each cycle of eventual neo-adjuvant chemotherapy, before surgery, then every six months during the next two years, and every year in the following three years ]
    Re-appearance of mutations non detectable after treatment or increase of ctDNA comparing to the nadir



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient with suspicion of ovarian or tubar epithelial cancer, or peritoneal primitive carcino-ma, without previous treatment for ovarian malignancy.
  2. Indication of preoperative and/or adjuvant chemotherapy.
  3. Age ≥ 18 years old.
  4. Patient affiliated to the ''National security'' regimen or beneficiary of this regimen
  5. Signed written informed consent prior to any screening procedures being performed

Non inclusion Criteria:

  1. Contraindication to surgical assessment.
  2. Pathological diagnosis of mucinous carcinoma.
  3. History of concurrent malignancy or malignancy within 5 years before study enrollment, (with the exceptions of adequately treated non melanomatous skin cancer or curatively re-sected noninvasive cervical cancer).
  4. Assessment by the investigator as being unable or unwilling to comply with the require-ments of the protocol.
  5. Patient in urgency situation, adult under legal protection, or unable to give his consent.

Exclusion Criteria after histological exam:

Any diagnostic that is not ovarian or tubar epithelial cancer, or peritoneal primitive carcinoma.


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): NCT03302884


Contacts
Contact: DOMINIQUE GENRE, MD 33 4 91 22 37 78 drci.up@ipc.unicancer.fr
Contact: Isabelle BOQUET, PhD 33 4 91 22 37 78 drci.up@ipc.unicancer.fr

Locations
France
Centre Jean Perrin Not yet recruiting
Clermont Ferrand, France, 63011
Contact: Christophe POMEL, MD         
Centre Oscar Lambret Not yet recruiting
Lille, France, 59000
Contact: Fabrice NARDUCCI, MD         
Institut Du Cancer de Montpellier Not yet recruiting
Montpellier, France, 34298
Contact: Pierre-Emmanuel COLOMBO, MD         
Sponsors and Collaborators
Institut Paoli-Calmettes
AstraZeneca
Investigators
Principal Investigator: Renaud SABATIER, MD Institut Paoli-Calmettes

Additional Information:
Responsible Party: Institut Paoli-Calmettes
ClinicalTrials.gov Identifier: NCT03302884     History of Changes
Other Study ID Numbers: CIDOC-IPC- 2016-008
First Posted: October 5, 2017    Key Record Dates
Last Update Posted: December 7, 2017
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Carcinoma
Recurrence
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Disease Attributes
Pathologic Processes
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders