Gynecologic CancerNCT03419689
Study Looking at Biomarkers in Ovarian Cancer
A study testing Tumour tissue collection, Blood sample collection and Ascites Collection in people with Gynecologic Cancer, run by University Health Network, Toronto at 7 sites in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecologic Cancer
- What is being tested?
- Tumour tissue collection, Blood sample collection and Ascites Collection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 510 participants
- Where
- 7 sitesCanada
- Study dates
- 8 Jan 2018to 8 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Canada7 sites, 6 recruiting
- Recruiting
Royal Victoria Regional Health Centre
Barrie, Ontario, L4M 6M2
Leah Jutzi, MD, 705-728-9090, jutzil@rvh.on.ca
Leah Jutzi, MD
- Active, not recruiting
Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2
- Recruiting
Kingston Health Sciences Centre
Kingston, Ontario, K7L 2V7
Josee-Lyne Ethier, M.D., josee-lyne.ethier@kingstonhsc.ca
- Recruiting
London Health Sciences Centre
London, Ontario
Stephen Welch, MD, 519-685-8600 ext. 53346, stephen.welch@lhsc.on.ca
Stephen Welch, MD
- Recruiting
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, K1H 8L6
Johanne Weberpals, M.D., jweberpals@toh.ca
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Helen MacKay, MD, 416-480-5145, helen.mackay@sunnybrook.ca
Helen MacKay, MD
- Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 1Z5
Amit Oza, M.D., 416-946-2818, amit.oza@uhn.ca
About this study
Official title: Biomarker Discovery Project in High Grade Serous 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.
- Conditions
- Gynecologic Cancer
- Being tested
- Tumour tissue collection, Blood sample collection, Ascites Collection, Fluid Collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumour tissue collectionProcedure or surgery
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 collectionProcedure or surgery
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 CollectionProcedure or surgery
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 CollectionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Sample Collection | Experimental | The following samples may be collected during the study:
* Tumour tissue samples
* Blood samples
* Ascites samples
* Other fluids requiring drainage Receives: Procedure: Tumour tissue collection; Procedure: Blood sample collection; Procedure: Ascites Collection; Procedure: Fluid Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genomic and immune signatures in terms of progression free survival
Short term (1-2 years) versus long term (5-10 years) survival
Measured: 10 years
Genomic and immune signatures in terms of overall survival
Short term (1-2 years) versus long term (5-10 years) survival
Measured: 10 years
Genomic and immune signatures in terms of response to treatments
Measured: 10 years
Genomic and immune signatures in terms of resistance to treatments
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start8 Jan 2018
- Primary completion8 Jun 2028 (estimated)
- Study completion8 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 510 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amit Oza, M.D., Principal investigator, Princess Margaret Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03419689
- Sponsor's protocol ID
- BioDIVA (17-5467)
- Status last verified
- Dec 2025
- First submitted
- 8 Aug 2017
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarker Discovery Project in High Grade Serous Ovarian Cancer
- ClinicalTrials.gov ID
- NCT03419689
- Acronym / sponsor ID
- BioDIVA (17-5467)
- Conditions
- Gynecologic Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 510 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- 8 Jun 2028 (estimated)
- Study completion
- 8 Jun 2028 (estimated)
- First posted
- 5 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sample Collection | Experimental | Procedure: Tumour tissue collection, Procedure: Blood sample collection, Procedure: Ascites Collection, Procedure: Fluid CollectionThe following samples may be collected during the study: * Tumour tissue samples * Blood samples * Ascites samples * Other fluids requiring drainage |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tumour tissue collectionTumour 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 or surgery | Sample Collection |
| Blood sample collectionBlood 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 or surgery | Sample Collection |
| Ascites CollectionAscites 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 or surgery | Sample Collection |
| Fluid CollectionAdditional 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. | Procedure or surgery | Sample Collection |
Primary outcome
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amit Oza, M.D. principal investigator
Princess Margaret Cancer Centre
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tumour tissue collection, Blood sample collection and Ascites Collection in people with Gynecologic Cancer, run by University Health Network, Toronto at 7 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amit Oza, M.D. (416-946-2818, amit.oza@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genomic and immune signatures in terms of progression free survival (time frame: 10 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.