CancerNCT06369441
Collection of Biological Specimens and Associated Health Information
An observational study of Cancer and Other Disease, run by Ovation.io, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to collect blood samples from a large number of individuals with cancer to create a database for researchers to use in future studies. Researchers may use this database to discover new ways to detect and treat cancer and other diseases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Other Disease
- How many people
- 10,000 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2024to Apr 2034
- How long will I take part?
- 10 Years
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults who have an active cancer diagnosis with confirmatory pathology results indicating solid tumor and/or hematologic malignancy
Who may be able to join
- Are patients of participating study site clinics/clinical groups
- Are adults (aged 18 or older)
- Have an active cancer diagnosis with confirmatory pathology results indicating solid tumor and/or hematologic malignancy
- Participants may have other active diagnoses with confirmatory clinical results
Who cannot join
- Individuals who lack the capacity to provide informed consent
- Individuals known to be prisoners at time of biological specimen collection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Ovation.io
Portland, Maine, 04101
Stephanie Balcaitis, 617-795-4947 ext. 2, ClinicalAffairs@ovation.io
Ed Stepanski, PhD, ClinicalAffairs@ovation.io
About this study
Official title: Collection of Biological Specimens and Associated Health Information for Secondary Research in Future Studies
The purpose of this study is to collect blood samples from a large number of individuals with cancer to create a database for researchers to use in future studies. Researchers may use this database to discover new ways to detect and treat cancer and other diseases. Future studies may use stored blood samples to discover how genes affect health and disease.
- Conditions
- Cancer, Other Disease
- Medical subject headings
- Neoplasms, Disease
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 |
|---|---|---|
| Oncology | Adults (aged 18 or older) who have an active cancer diagnosis with confirmatory pathology results indicating solid tumor and/or hematologic malignancy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biorepository
The objective of this study is to establish a biorepository and database of specimens to enable future research on the role of genetic factors in the biological mechanisms of diseases, including cancer, and treatment outcomes.
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 posted17 Apr 2024
- Study startApr 2024 (estimated)
- Primary completionApr 2025 (estimated)
- Study completionApr 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Ovation.io, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pauline Gee, PhD, Study director, VP, Clinical Affairs, Ovation.io
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06369441
- Sponsor's protocol ID
- Ovation-23-001
- Status last verified
- Apr 2024
- First submitted
- 11 Apr 2024
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All future research requests will be submitted to Ovation.io and reviewed to ensure that they are consistent with the permissions described in the informed consent form by Ovation.io staff. If there is a question regarding whether or not the research request is consistent with the informed consent form and Ovation.io's biorepository policies, Ovation.io will request review and approval by an appropriate IRB. Research teams whose study aims are in concordance with the purpose of the Ovation.io biorepository, may be granted access to specified coded datasets.In the case that a secondary research protocol requires biological specimen analysis to produce the requested dataset, Ovation.io will conduct the analysis on the relevant biological specimens stored in the biorepository and provide the results to the research team in the form of a de-identified dataset.
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Biological Specimens and Associated Health Information for Secondary Research in Future Studies
- ClinicalTrials.gov ID
- NCT06369441
- Acronym / sponsor ID
- Ovation-23-001
- Conditions
- Cancer, Other Disease
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Ovation.io, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2024 (estimated)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2034 (estimated)
- First posted
- 17 Apr 2024 (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.
The purpose of this study is to collect blood samples from a large number of individuals with cancer to create a database for researchers to use in future studies. Researchers may use this database to discover new ways to detect and treat cancer and other diseases. Future studies may use stored blood samples to discover how genes affect health and disease.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oncology | – | –Adults (aged 18 or older) who have an active cancer diagnosis with confirmatory pathology results indicating solid tumor and/or hematologic malignancy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults who have an active cancer diagnosis with confirmatory pathology results indicating solid tumor and/or hematologic malignancy
Key inclusion criteria (4 listed)
- Are patients of participating study site clinics/clinical groups
- Are adults (aged 18 or older)
- Have an active cancer diagnosis with confirmatory pathology results indicating solid tumor and/or hematologic malignancy
- Participants may have other active diagnoses with confirmatory clinical results
Key exclusion criteria (2 listed)
- Individuals who lack the capacity to provide informed consent
- Individuals known to be prisoners at time of biological specimen 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
Biorepository
Time frame: 10 years
The objective of this study is to establish a biorepository and database of specimens to enable future research on the role of genetic factors in the biological mechanisms of diseases, including cancer, and treatment outcomes.
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 17 Apr 2024.
- Individual participant dataSharing planned: Yes. All future research requests will be submitted to Ovation.io and reviewed to ensure that they are consistent with the permissions described in the informed consent form by Ovation.io staff. If there is a question regarding whether or not the research request is consistent with the informed consent form and Ovation.io's biorepository policies, Ovation.io will request review and approval by an appropriate IRB. Research teams whose study aims are in concordance with the purpose of the Ovation.io biorepository, may be granted access to specified coded datasets.In the case that a secondary research protocol requires biological specimen analysis to produce the requested dataset, Ovation.io will conduct the analysis on the relevant biological specimens stored in the biorepository and provide the results to the research team in the form of a de-identified dataset.
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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.
Pauline Gee, PhD study director
VP, Clinical Affairs, Ovation.io
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 Cancer and Other Disease, run by Ovation.io, Inc. at 1 site in United States.
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 4 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: opening soon, as of the sponsor's last update on 17 Apr 2024. 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 United States. 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 Pauline Gee, PhD (6177954947 ext. 2, ClinicalAffairs@ovation.io), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biorepository (time frame: 10 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 17 Apr 2024.