Testing Tumour tissue collection with Blood sample collection for gynecologic cancer
Official title: Study Looking at Biomarkers in Ovarian Cancer
Biomarker Discovery Project in High Grade Serous Ovarian Cancer
- 1 group
- Sites in Barrie, Hamilton and 4 more cities
- Recruiting
Interventions (4)
- Medical 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
- Medical 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
- Medical 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
- Medical 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.
Canadian Sites (7)
6 of 7 recruiting
- Recruiting
Royal Victoria Regional Health Centre
Barrie, Ontario
- Recruiting
Kingston Health Sciences Centre
Kingston, Ontario
- Recruiting
London Health Sciences Centre
London, Ontario
- Recruiting
The Ottawa Hospital Cancer Centre
Ottawa, Ontario
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario
- Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario
- Not currently recruiting
Juravinski Cancer Centre
Hamilton, Ontario
Eligibility Criteria
See who this study is looking for11 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
- +Histological diagnosis of stage III or IV high grade serous ovarian, tubal or primary peritoneal cancer.
- +Must be 18 years of age or older.
- +Have a life expectancy greater than or equal to 6 months.
- +Able to provide adequate informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →.
- +Willing to undergo blood or fluid collection and tumour biopsy
- +Archival tissue must be available for patients that are enrolledEnrolmentThe number of participants a study plans to include, or has included.Read more → at the time of progression.
- +Patients enrolled at the time of surgery must agree to have part of their tumour used for the purpose of the study.
Exclusion
- −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.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a way to identify or measure a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
Everyone in this study is in one group, which receives one or more of: Tumour tissue collection, Blood sample collection, Ascites Collection and Fluid Collection.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
There is only one group in this study, so there is no assignment to different treatments.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study lists female participants only.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 510 people.
The study is currently expected to finish around June 2028.
The main measurement is taken over: 10 years.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Genomic and immune signatures in terms of progression free survival — measured over 10 years.
Genomic and immune signatures in terms of overall survival — measured over 10 years.
Genomic and immune signatures in terms of response to treatments — measured over 10 years.
Genomic and immune signatures in terms of resistance to treatments — measured over 10 years.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT03419689 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Tumour tissue collectionProcedure
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
From the trial registry — its own words, unedited.
What a procedure is here: A surgery, technique or clinical procedure being studied.
Read the full explanation → · in clinical review
About Blood sample collectionProcedure
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
From the trial registry — its own words, unedited.
What a procedure is here: A surgery, technique or clinical procedure being studied.
Read the full explanation → · in clinical review
About Ascites CollectionProcedure
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
From the trial registry — its own words, unedited.
What a procedure is here: A surgery, technique or clinical procedure being studied.
Read the full explanation → · in clinical review
About Fluid CollectionProcedure
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.
From the trial registry — its own words, unedited.
What a procedure is here: A surgery, technique or clinical procedure being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
There is only one group in this study, so there is no assignment to different treatments.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It lists female participants only.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 10 years.
The study as a whole is currently expected to finish around 2028-06-08.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 510 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 6 locations, including: Barrie, Ontario, Canada; Hamilton, Ontario, Canada; Kingston, Ontario, Canada; London, Ontario, Canada; Ottawa, Ontario, Canada; Toronto, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
Think this trial might be right for you?
Complete a quick intake form and we will match you with this and other relevant trials based on your medical profile.
See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.