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Recruiting NCT03419689

Study Looking at Biomarkers in Ovarian Cancer

No phase Interventional Gynecologic Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tumour tissue collection, Blood sample collection, Ascites Collection, Fluid Collection.
Who it may be relevant to
Registry conditions: Gynecologic Cancer. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Biomarker Discovery Project in High Grade Serous Ovarian Cancer

Overview

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.

Interventions

  • Procedure Tumour tissue collection
    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
  • Procedure Blood sample collection
    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
  • Procedure Ascites Collection
    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
  • Procedure Fluid Collection
    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.

Primary outcome measures

  • Genomic and immune signatures in terms of progression free survival [Time frame: 10 years]
  • Genomic and immune signatures in terms of overall survival [Time frame: 10 years]
  • Genomic and immune signatures in terms of response to treatments [Time frame: 10 years]
  • Genomic and immune signatures in terms of resistance to treatments [Time frame: 10 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Canada · 7 centers
  • Royal Victoria Regional Health Centre — Barrie
  • Juravinski Cancer Centre — Hamilton
  • Kingston Health Sciences Centre — Kingston
  • London Health Sciences Centre — London
  • The Ottawa Hospital Cancer Centre — Ottawa
  • Sunnybrook Health Sciences Centre — Toronto
  • Princess Margaret Cancer Centre — Toronto

Identifiers

NCT: NCT03419689 · BioDIVA (17-5467)

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗