Epithelial Ovarian CancerNCT02952521
Ovarian Tumor Biopsies to Study Response to Treatments
An observational study of Epithelial Ovarian Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
This is a research study to look at differences in tumor tissue from ovarian cancer patients that may help to determine response and resistance to treatments. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Epithelial Ovarian Cancer
- What is being tested?
- Blood Draw and Tumor Tissue Biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 5 participants
- Where
- 1 siteCanada
- Study dates
- 25 Jan 2017to 28 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Patients with histological diagnosis of epithelial ovarian cancer
Who may be able to join
- Age ≥18 years.
- Histological diagnosis of epithelial ovarian cancer
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
- Life expectancy of greater than 3 months
- Diagnosis of epithelial ovarian cancer undergoing chemotherapy as part of standard care or a clinical trial OR receiving a targeted therapy with a targeted agent
- Must be agreeable to paired biopsies
- Must have disease amenable to paired biopsy.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Any contraindication to biopsy
- Need for anticoagulation that cannot be interrupted
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Paired Biopsies to Develop a Cellular Signature
This is a research study to look at differences in tumor tissue from ovarian cancer patients that may help to determine response and resistance to treatments.
Read the detailed description
Ovarian cancer participants will be asked to have two tumor biopsies during the research study. The first biopsy will be done prior to receiving the participants' assigned treatments as a part of their cancer care and the second biopsy will be done about 3-7 days after starting treatment. Participants who will undergo neoadjuvant treatment and then surgery, will also have their tumor tissue collected during surgery. Participants whose disease worsens while on treatment will also be asked to have an additional, optional tumor biopsy.
The tumor tissue samples will be studied to look at certain proteins and enzymes, including enzymes called kinomes, that may be important in determining response and resistance to the treatment that participants will receive as a part of their cancer care.
- Conditions
- Epithelial Ovarian Cancer
- Being tested
- Blood Draw, Tumor Tissue Biopsy
- Medical subject headings
- Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood DrawProcedure or surgery
CA125 and ctDNA
Tumor Tissue BiopsyProcedure or surgery
Only collected at time of surgery if patient undergoes surgical debulking
| Study group | Role | What they receive |
|---|---|---|
| Epithelial ovarian cancer | * Whole blood sample collection
* Up to 3 fresh tumor tissue core biopsies
* Tumor tissue sample taken from tumor tissue already removed from surgery (if surgery is planned) Receives: Procedure: Blood Draw; Procedure: Tumor Tissue Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pearson correlation for changes between kinome and CA125
Measured: 5 years
Paired T-test for differences in kinome between responders and non-responders
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2016 (estimated)
- Study start25 Jan 2017
- Primary completion28 Oct 2021
- Study completion28 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epithelial Ovarian 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
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
- NCT02952521
- Sponsor's protocol ID
- KINOME
- Status last verified
- May 2022
- First submitted
- 31 Oct 2016
- Last updated
- 10 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paired Biopsies to Develop a Cellular Signature
- ClinicalTrials.gov ID
- NCT02952521
- Acronym / sponsor ID
- KINOME
- Conditions
- Epithelial Ovarian Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 25 Jan 2017 (actual)
- Primary completion
- 28 Oct 2021 (actual)
- Study completion
- 28 Oct 2021 (actual)
- First posted
- 2 Nov 2016 (estimated)
- 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 research study to look at differences in tumor tissue from ovarian cancer patients that may help to determine response and resistance to treatments.
Detailed description
Ovarian cancer participants will be asked to have two tumor biopsies during the research study. The first biopsy will be done prior to receiving the participants' assigned treatments as a part of their cancer care and the second biopsy will be done about 3-7 days after starting treatment. Participants who will undergo neoadjuvant treatment and then surgery, will also have their tumor tissue collected during surgery. Participants whose disease worsens while on treatment will also be asked to have an additional, optional tumor biopsy.
The tumor tissue samples will be studied to look at certain proteins and enzymes, including enzymes called kinomes, that may be important in determining response and resistance to the treatment that participants will receive as a part of their cancer care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Epithelial ovarian cancer | – | Procedure: Blood Draw, Procedure: Tumor Tissue Biopsy* Whole blood sample collection * Up to 3 fresh tumor tissue core biopsies * Tumor tissue sample taken from tumor tissue already removed from surgery (if surgery is planned) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with histological diagnosis of epithelial ovarian cancer
Key inclusion criteria (8 listed)
- Age ≥18 years.
- Histological diagnosis of epithelial ovarian cancer
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
- Life expectancy of greater than 3 months
- Diagnosis of epithelial ovarian cancer undergoing chemotherapy as part of standard care or a clinical trial OR receiving a targeted therapy with a targeted agent
Key exclusion criteria (2 listed)
- Any contraindication to biopsy
- Need for anticoagulation that cannot be interrupted
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 |
|---|---|---|
| Blood DrawCA125 and ctDNA | Procedure or surgery | Epithelial ovarian cancer |
| Tumor Tissue BiopsyOnly collected at time of surgery if patient undergoes surgical debulking | Procedure or surgery | Epithelial ovarian cancer |
Primary outcome
Pearson correlation for changes between kinome and CA125
Time frame: 5 years
Paired T-test for differences in kinome between responders and non-responders
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Amit Oza, M.D. principal investigator
Princess Margaret Cancer Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epithelial Ovarian Cancer, run by University Health Network, Toronto at 1 site 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 2 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: finished, as of the sponsor's last update on 10 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pearson correlation for changes between kinome and CA125 (time frame: 5 years). The study lists 2 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 10 May 2022; AzTrials last refreshed its copy on 7 Nov 2026.