Study Looking at Biomarkers in Ovarian Cancer

Study Overview
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Brief Summary
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This is a sample study that will collect biological samples (blood, tumor tissue, ascites, and/or other fluids) from gynecological cancer patients for biomarker research. In addition, the results of the testing done on the samples will be given to the participant's treating physician who may use the information to guide treatment decisions.

Official Title
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Biomarker Discovery Project in High Grade Serous Ovarian Cancer

Conditions
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Gynecologic Cancer

Intervention / Treatment
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* Procedure: Tumour tissue collection
* Procedure: Blood sample collection
* Procedure: Ascites Collection
* Procedure: Fluid Collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histological diagnosis of stage III or IV high grade serous ovarian, tubal or primary peritoneal cancer. Must be 18 years of age or older. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1. Have a life expectancy greater than or equal to 6 months. Able to provide adequate informed consent. Willing to undergo blood or fluid collection and tumour biopsy Patients enrolled at the time of surgery must agree to have part of their tumour used for the purpose of the study. Archival tissue must be available for patients that are enrolled at the time of progression. Exclusion Criteria: Must not have early stage (I and II) high grade serous, tubal or primary peritoneal cancer. Must not have other tumour histology other than high grade serous. Must not have contraindication to tumour biopsy and/or blood sampling.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sample Collection<br>The following samples may be collected during the study: Tumour tissue samples Blood samples Ascites samples Other fluids requiring drainage | Procedure: Tumour tissue collection<br>* Tumour tissue will be taken from samples already removed from surgery or biopsy or by new tumour biopsies: At the time of diagnosis or progression Any surgical procedures for management of tumour related medical conditions At each subsequent relapse or disease progression<br>Procedure: Blood sample collection<br>* Blood samples will be taken: At the time of first diagnosis About 1 week after starting any treatment At each radiological response assessment At each subsequent relapse or disease progression<br>Procedure: Ascites Collection<br>* Ascites will be collected if paracentesis is required during any of the following time points: At the time of diagnosis or progression Any surgical procedures for management of tumour related medical conditions At each subsequent relapse or disease progression<br>Procedure: Fluid Collection<br>* Additional fluid will be collected at any time a procedure for clinical management that involves the drainage of fluid (i.e. thoracentesis, or drainage of cystic lesion) is required.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genomic and immune signatures in terms of progression free survival | Short term (1-2 years) versus long term (5-10 years) survival | 10 years | 
| Genomic and immune signatures in terms of overall survival | Short term (1-2 years) versus long term (5-10 years) survival | 10 years | 
| Genomic and immune signatures in terms of response to treatments |  | 10 years | 
| Genomic and immune signatures in terms of resistance to treatments |  | 10 years |