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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).
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with (suspicion of) primary EOC |
| ||
| Patients with recurrent EOC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | Observational study, no intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Association between the mMDSC/DC ratio in PBMCs in patients with recurrent EOC before the start of treatment and OS | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Association between the mMDSC/DC ratio in PBMCs in patients with recurrent EOC before the start of treatment and PFS | 5 years | |
| Association between the mMDSC/DC ratio in PBMCs in patients with primary EOC before the start of treatment and OS | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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The study will be carried out in patients with primary and recurrent EOC considered eligible for treatment with surgery, chemotherapy and/or immunotherapy.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Judith R Kroep, MD PhD | Contact | +31715263464 | j.r.kroep@lumc.nl | |
| A F de Groot, MD | Contact | +31715299126 | a.f.de_groot@lumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Judith R Kroep, MD PhD | Leiden University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leiden University Medical Center | Recruiting | Leiden | Netherlands |
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| ID | Term |
|---|---|
| D000077216 | Carcinoma, Ovarian Epithelial |
| D005185 | Fallopian Tube Neoplasms |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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Tumor material, ascites and blood samples before and/or during therapy.
| Association between the mMDSC/DC ratio in PBMCs in patients with primary EOC before the start of treatment and PFS | 5 years |
| Interaction between the mMDSC/DC ratio in PBMCs and EOC groups on OS | 5 years |
| Interaction between the mMDSC/DC ratio in PBMCs and EOC groups on PFS | 5 years |
| Association between mMDSC/DC ratio in PBMCs measured at different time points in patients with primary EOC and OS | 5 years |
| Association between mMDSC/DC ratio in PBMCs measured at different time points in patients with recurrent EOC and OS | 5 years |
| Association between mMDSC/DC ratio in PBMCs measured at different time points in patients with primary EOC and PFS | 5 years |
| Association between mMDSC/DC ratio in PBMCs measured at different time points in patients with recurrent EOC and PFS | 5 years |
| Composition/counts of myeloid cells in PBMCs in patients with primary EOC before and during treatment and the association with OS | 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 | 5 years |
| Composition/counts of myeloid cells in PBMCs in patients with recurrent EOC before and during treatment and the association with OS | 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 | 5 years |
| Composition/counts of myeloid cells in PBMCs in patients with primary EOC before and during treatment and the association with PFS | 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 | 5 years |
| Composition/counts of myeloid cells in PBMCs in patients with recurrent EOC before and during treatment and the association with PFS | 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 | 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) | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 5 years |
| D010051 |
| Ovarian Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005184 | Fallopian Tube Diseases |