Ovarian NeoplasmsNCT02811224
Ovarian Cancer Hemoscope Trial
An observational study of Ovarian Neoplasms, run by Scripps Translational Science Institute.
Trial summary
This is a prospective, gold standard observational trial designed to enroll consecutive, consenting ovarian cancer patients for the purpose of determining sensitivity of an assay that detects circulating tumor DNA. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Neoplasms
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- May 2016to Jul 2030
- Phase
- Observational
- 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
Study population: Women undergoing surgery as part of the treatment plan for ovarian cancer or a benign gynecological neoplasm.
Who may be able to join
- Case Group
- Patients with ovarian cancer undergoing surgery (all stages)
- Over 18 years old
- Control Group
- Patients with a benign gynecological condition undergoing surgery
- Over 18 years old
Who cannot join
- Previous cancer diagnosis (all)
- Radiation therapy before surgical treatment
- Bone marrow transplant
- Chemotherapy before surgical treatment
- Invasive procedure resulting in damage to tissue (e.g., surgery, biopsy, thermal ablation) in the 7 days prior to baseline (pre-surgical) blood collection
About this study
This is a prospective, gold standard observational trial designed to enroll consecutive, consenting ovarian cancer patients for the purpose of determining sensitivity of an assay that detects circulating tumor DNA. This observational pilot trial will also be used to examine the genetic variants/mutations present in the tumor tissue DNA.
- Conditions
- Ovarian Neoplasms
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ovarian Cancer | Not described | |
| Benign Neoplasm | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of an assay that detects circulating tumor DNA
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2016 (estimated)
- Study startMay 2016
- Primary completionJun 2025 (estimated)
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian NeoplasmsStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scripps Translational Science Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02811224
- Sponsor's protocol ID
- 15-6644
- Status last verified
- Jan 2025
- First submitted
- 21 Jun 2016
- Last updated
- 16 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ovarian Cancer Hemoscope Trial
- ClinicalTrials.gov ID
- NCT02811224
- Acronym / sponsor ID
- 15-6644
- Conditions
- Ovarian Neoplasms
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Scripps Translational Science InstituteUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jul 2030 (estimated)
- First posted
- 23 Jun 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 prospective, gold standard observational trial designed to enroll consecutive, consenting ovarian cancer patients for the purpose of determining sensitivity of an assay that detects circulating tumor DNA. This observational pilot trial will also be used to examine the genetic variants/mutations present in the tumor tissue DNA.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ovarian Cancer | – | – |
| Benign Neoplasm | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women undergoing surgery as part of the treatment plan for ovarian cancer or a benign gynecological neoplasm.
Key inclusion criteria (6 listed)
- Case Group
- Patients with ovarian cancer undergoing surgery (all stages)
- Over 18 years old
- Control Group
- Patients with a benign gynecological condition undergoing surgery
Key exclusion criteria (5 listed)
- Previous cancer diagnosis (all)
- Radiation therapy before surgical treatment
- Bone marrow transplant
- Chemotherapy before surgical treatment
- Invasive procedure resulting in damage to tissue (e.g., surgery, biopsy, thermal ablation) in the 7 days prior to baseline (pre-surgical) blood collection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity of an assay that detects circulating tumor DNA
Time frame: 3 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 16 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Neoplasms, run by Scripps Translational Science Institute.
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 6 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 16 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Sensitivity of an assay that detects circulating tumor DNA (time frame: 3 years). 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 16 Jan 2025.