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Recruiting

NCT Number: NCT03419689

Study Looking at Biomarkers in Ovarian Cancer

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.

Recruiting

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Key information

Conditions

Gynecologic Cancer

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Royal Victoria Regional Health Centre, Barrie, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tumour tissue collection

Procedure

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

blood sample collection

Procedure

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

Ascites Collection

Procedure

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

Fluid Collection

Procedure

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 outcomes

  1. Genomic and immune signatures in terms of progression free survival

    Time frame: 10 years

    Short term (1-2 years) versus long term (5-10 years) survival

  2. Genomic and immune signatures in terms of overall survival

    Time frame: 10 years

    Short term (1-2 years) versus long term (5-10 years) survival

  3. Genomic and immune signatures in terms of response to treatments

    Time frame: 10 years

  4. Genomic and immune signatures in terms of resistance to treatments

    Time frame: 10 years

Study contacts

Contact information is provided by the study sponsor or research team.

Amit Oza, M.D.

CONTACT

[email protected]

416-946-2818

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

Biomarker Discovery Project in High Grade Serous Ovarian Cancer

Important dates

Study start
2018
Primary completion
2028
Study completion
2028
First posted
Feb 5, 2018
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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