Determining Prognostic Immune Markers in Patients With Ovarian Cancer

Epithelial Ovarian Cancer Clinical Trial

— IMPrOVE  

Official title:

Determining Prognostic Immune Markers in Patients With Ovarian Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03862677
• Other study ID #: NL66869.058.19
• Status: Recruiting
• Start date: August 15, 2020
• Est. completion date: January 31, 2027

Study information

• Verified date: March 2021
• Source: Leiden University Medical Center
• Contact: Judith R Kroep, MD PhD
• Phone: +31715263464
• Email: j.r.kroep[@]lumc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: January 31, 2027
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Epithelial Ovarian Cancer
• Ovarian Neoplasms

Intervention

Other:
• No intervention
Observational study, no intervention

Locations

Country	Name	City	State
Netherlands	Leiden University Medical Center	Leiden

Sponsors (1)

Lead Sponsor	Collaborator
Leiden University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Association between the mMDSC/DC ratio in PBMCs in patients with recurrent EOC before the start of treatment and OS		5 years
Secondary	Association between the mMDSC/DC ratio in PBMCs in patients with recurrent EOC before the start of treatment and PFS		5 years
Secondary	Association between the mMDSC/DC ratio in PBMCs in patients with primary EOC before the start of treatment and OS		5 years
Secondary	Association between the mMDSC/DC ratio in PBMCs in patients with primary EOC before the start of treatment and PFS		5 years
Secondary	Interaction between the mMDSC/DC ratio in PBMCs and EOC groups on OS		5 years
Secondary	Interaction between the mMDSC/DC ratio in PBMCs and EOC groups on PFS		5 years
Secondary	Association between mMDSC/DC ratio in PBMCs measured at different time points in patients with primary EOC and OS		5 years
Secondary	Association between mMDSC/DC ratio in PBMCs measured at different time points in patients with recurrent EOC and OS		5 years
Secondary	Association between mMDSC/DC ratio in PBMCs measured at different time points in patients with primary EOC and PFS		5 years
Secondary	Association between mMDSC/DC ratio in PBMCs measured at different time points in patients with recurrent EOC and PFS		5 years
Secondary	Composition/counts of myeloid cells in PBMCs in patients with primary EOC before and during treatment and the association with OS		5 years
Secondary	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		5 years
Secondary	Composition/counts of myeloid cells in PBMCs in patients with recurrent EOC before and during treatment and the association with OS		5 years
Secondary	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		5 years
Secondary	Composition/counts of myeloid cells in PBMCs in patients with primary EOC before and during treatment and the association with PFS		5 years
Secondary	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		5 years
Secondary	Composition/counts of myeloid cells in PBMCs in patients with recurrent EOC before and during treatment and the association with PFS		5 years
Secondary	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		5 years
Secondary	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)		5 years
Secondary	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		5 years
Secondary	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		5 years
Secondary	Immune contexture of primary tumors by determination of the intratumoral immune subset numbers in fresh and archived tumor material and the association with OS		5 years
Secondary	Immune contexture of recurrent tumors by determination of the intratumoral immune subset numbers in fresh and archived tumor material and the association with OS		5 years
Secondary	Immune contexture of primary tumors by determination of the intratumoral immune subset numbers in fresh and archived tumor material and the association with PFS		5 years
Secondary	Immune contexture of recurrent tumors by determination of the intratumoral immune subset numbers in fresh and archived tumor material and the association with PFS		5 years
Secondary	Immune contexture of ascites by determination of the immune subset numbers in ascites fluid of patients with primary EOC and the association with OS		5 years
Secondary	Immune contexture of ascites by determination of the immune subset numbers in ascites fluid of patients with recurrent EOC and the association with OS		5 years
Secondary	Immune contexture of ascites by determination of the immune subset numbers in ascites fluid of patients with primary EOC and the association with PFS		5 years
Secondary	Immune contexture of ascites by determination of the immune subset numbers in ascites fluid of patients with recurrent EOC and the association with PFS		5 years