Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03862677
Recruitment Status : Recruiting
First Posted : March 5, 2019
Last Update Posted : February 21, 2020
Sponsor:
Information provided by (Responsible Party):
J.R. Kroep, Leiden University Medical Center

Tracking Information
First Submitted Date February 26, 2019
First Posted Date March 5, 2019
Last Update Posted Date February 21, 2020
Estimated Study Start Date February 25, 2020
Estimated Primary Completion Date February 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 1, 2019)
Association between the mMDSC/DC ratio in PBMCs in patients with recurrent EOC before the start of treatment and OS [ Time Frame: 5 years ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 1, 2019)
  • Association between the mMDSC/DC ratio in PBMCs in patients with recurrent EOC before the start of treatment and PFS [ Time Frame: 5 years ]
  • Association between the mMDSC/DC ratio in PBMCs in patients with primary EOC before the start of treatment and OS [ Time Frame: 5 years ]
  • Association between the mMDSC/DC ratio in PBMCs in patients with primary EOC before the start of treatment and PFS [ Time Frame: 5 years ]
  • Interaction between the mMDSC/DC ratio in PBMCs and EOC groups on OS [ Time Frame: 5 years ]
  • Interaction between the mMDSC/DC ratio in PBMCs and EOC groups on PFS [ Time Frame: 5 years ]
  • Association between mMDSC/DC ratio in PBMCs measured at different time points in patients with primary EOC and OS [ Time Frame: 5 years ]
  • Association between mMDSC/DC ratio in PBMCs measured at different time points in patients with recurrent EOC and OS [ Time Frame: 5 years ]
  • Association between mMDSC/DC ratio in PBMCs measured at different time points in patients with primary EOC and PFS [ Time Frame: 5 years ]
  • Association between mMDSC/DC ratio in PBMCs measured at different time points in patients with recurrent EOC and PFS [ Time Frame: 5 years ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Determining Prognostic Immune Markers in Patients With Ovarian Cancer
Official Title Determining Prognostic Immune Markers in Patients With Ovarian Cancer
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).
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Tumor material, ascites and blood samples before and/or during therapy.
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.
Condition Epithelial Ovarian Cancer
Intervention Other: No intervention
Observational study, no intervention
Study Groups/Cohorts
  • Patients with (suspicion of) primary EOC
    Intervention: Other: No intervention
  • Patients with recurrent EOC
    Intervention: Other: No intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 1, 2019)
300
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 31, 2027
Estimated Primary Completion Date February 1, 2022   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
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
Listed Location Countries Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number NCT03862677
Other Study ID Numbers NL66869.058.19
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party J.R. Kroep, Leiden University Medical Center
Study Sponsor Leiden University Medical Center
Collaborators Not Provided
Investigators
Principal Investigator: Judith R Kroep, MD PhD Leiden University Medical Center
PRS Account Leiden University Medical Center
Verification Date February 2020