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Determining Prognostic Immune Markers in Patients With Ovarian Cancer (IMPrOVE)

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ClinicalTrials.gov Identifier: NCT03862677
Recruitment Status : Not yet recruiting
First Posted : March 5, 2019
Last Update Posted : March 5, 2019
Sponsor:
Information provided by (Responsible Party):
J.R. Kroep, Leiden University Medical Center

Brief Summary:
The IMPRoVE study is a prospective, non-interventional, explorative cohort study to determine prognostic immune markers in patients with epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer (EOC).

Condition or disease Intervention/treatment
Epithelial Ovarian Cancer Other: No intervention

Detailed Description:
Tumor material, ascites (if possible) and blood samples for immune monitoring will be collected from patients with primary and recurrent EOC undergoing surgery, chemotherapy and/or immunotherapy.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Determining Prognostic Immune Markers in Patients With Ovarian Cancer
Estimated Study Start Date : May 1, 2019
Estimated Primary Completion Date : February 1, 2022
Estimated Study Completion Date : January 31, 2027


Group/Cohort Intervention/treatment
Patients with (suspicion of) primary EOC Other: No intervention
Observational study, no intervention

Patients with recurrent EOC Other: No intervention
Observational study, no intervention




Primary Outcome Measures :
  1. Association between the mMDSC/DC ratio in PBMCs in patients with recurrent EOC before the start of treatment and OS [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Association between the mMDSC/DC ratio in PBMCs in patients with recurrent EOC before the start of treatment and PFS [ Time Frame: 5 years ]
  2. Association between the mMDSC/DC ratio in PBMCs in patients with primary EOC before the start of treatment and OS [ Time Frame: 5 years ]
  3. Association between the mMDSC/DC ratio in PBMCs in patients with primary EOC before the start of treatment and PFS [ Time Frame: 5 years ]
  4. Interaction between the mMDSC/DC ratio in PBMCs and EOC groups on OS [ Time Frame: 5 years ]
  5. Interaction between the mMDSC/DC ratio in PBMCs and EOC groups on PFS [ Time Frame: 5 years ]
  6. Association between mMDSC/DC ratio in PBMCs measured at different time points in patients with primary EOC and OS [ Time Frame: 5 years ]
  7. Association between mMDSC/DC ratio in PBMCs measured at different time points in patients with recurrent EOC and OS [ Time Frame: 5 years ]
  8. Association between mMDSC/DC ratio in PBMCs measured at different time points in patients with primary EOC and PFS [ Time Frame: 5 years ]
  9. Association between mMDSC/DC ratio in PBMCs measured at different time points in patients with recurrent EOC and PFS [ Time Frame: 5 years ]
  10. Composition/counts of myeloid cells in PBMCs in patients with primary EOC before and during treatment and the association with OS [ Time Frame: 5 years ]
  11. Function of myeloid cells (assessed by functional suppression assay) in PBMCs in patients with primary EOC before and during treatment and the association with OS [ Time Frame: 5 years ]
  12. Composition/counts of myeloid cells in PBMCs in patients with recurrent EOC before and during treatment and the association with OS [ Time Frame: 5 years ]
  13. Function of myeloid cells (assessed by functional suppression assay) in PBMCs in patients with recurrent EOC before and during treatment and the association with OS [ Time Frame: 5 years ]
  14. Composition/counts of myeloid cells in PBMCs in patients with primary EOC before and during treatment and the association with PFS [ Time Frame: 5 years ]
  15. Function of myeloid cells (assessed by functional suppression assay) in PBMCs in patients with primary EOC before and during treatment and the association with PFS [ Time Frame: 5 years ]
  16. Composition/counts of myeloid cells in PBMCs in patients with recurrent EOC before and during treatment and the association with PFS [ Time Frame: 5 years ]
  17. Function of myeloid cells (assessed by functional suppression assay) in PBMCs in patients with recurrent EOC before and during treatment and the association with PFS [ Time Frame: 5 years ]
  18. Influence of the mMDSC/DC ratio and separate immune cell populations on the tumor specific and general immune response (assessed by mixed lymphocyte reaction, functional suppression assay and lymphocyte stimulation test) [ Time Frame: 5 years ]
  19. Determined, optimized and validated optimal cut-off point for the macrophage/DC ratio and the mMDSC/DC ratio in PBMCs in patients with primary EOC for the different chemotherapeutic and immunotherapeutic treatment modalities [ Time Frame: 5 years ]
  20. Determined, optimized and validated optimal cut-off point for the macrophage/DC ratio and the mMDSC/DC ratio in PBMCs in patients with recurrent EOC for the different chemotherapeutic and immunotherapeutic treatment modalities [ Time Frame: 5 years ]
  21. Immune contexture of primary tumors by determination of the intratumoral immune subset numbers in fresh and archived tumor material and the association with OS [ Time Frame: 5 years ]
  22. Immune contexture of recurrent tumors by determination of the intratumoral immune subset numbers in fresh and archived tumor material and the association with OS [ Time Frame: 5 years ]
  23. Immune contexture of primary tumors by determination of the intratumoral immune subset numbers in fresh and archived tumor material and the association with PFS [ Time Frame: 5 years ]
  24. Immune contexture of recurrent tumors by determination of the intratumoral immune subset numbers in fresh and archived tumor material and the association with PFS [ Time Frame: 5 years ]
  25. Immune contexture of ascites by determination of the immune subset numbers in ascites fluid of patients with primary EOC and the association with OS [ Time Frame: 5 years ]
  26. Immune contexture of ascites by determination of the immune subset numbers in ascites fluid of patients with recurrent EOC and the association with OS [ Time Frame: 5 years ]
  27. Immune contexture of ascites by determination of the immune subset numbers in ascites fluid of patients with primary EOC and the association with PFS [ Time Frame: 5 years ]
  28. Immune contexture of ascites by determination of the immune subset numbers in ascites fluid of patients with recurrent EOC and the association with PFS [ Time Frame: 5 years ]

Biospecimen Retention:   Samples With DNA
Tumor material, ascites and blood samples before and/or during therapy.


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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 will be carried out in patients with primary and recurrent EOC considered eligible for treatment with surgery, chemotherapy and/or immunotherapy.
Criteria

Inclusion Criteria:

  • Patients with (suspicion of) primary or recurrent EOC with an indication for surgery, chemotherapy and/or immunotherapy.
  • Age ≥18 years.
  • WHO performance status 0-2.
  • Accessible for treatment and follow-up.
  • Written informed consent.

Exclusion Criteria:

  • Other active malignancy in past 5 years prior to entry into the study, except for treated non-melanoma skin cancer.
  • Any known severe infection like HIV, hepatitis A, B and C.
  • Receiving immune suppressive treatment.
  • Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent.

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): NCT03862677


Contacts
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Contact: Judith R Kroep, MD PhD +31715263464 j.r.kroep@lumc.nl
Contact: A F de Groot, MD +31715299126 a.f.de_groot@lumc.nl

Locations
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Netherlands
Leiden University Medical Center Not yet recruiting
Leiden, Netherlands
Contact: Judith R Kroep, MD PhD         
Sponsors and Collaborators
Leiden University Medical Center
Investigators
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Principal Investigator: Judith R Kroep, MD PhD Leiden University Medical Center

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Responsible Party: J.R. Kroep, Principal Investigator MD PhD, Leiden University Medical Center
ClinicalTrials.gov Identifier: NCT03862677     History of Changes
Other Study ID Numbers: NL66869.058.19
First Posted: March 5, 2019    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 J.R. Kroep, Leiden University Medical Center:
Epithelial ovarian cancer
Fallopian tube cancer
Primary peritoneal cancer
EOC
Immunity
IMPrOVE
Prognostic
Immune markers
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders
Carcinoma