Collection of Biological Specimens and Associated Health Information

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cancer; Other Disease

• Study Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

• Study Contact: Name: Pauline Gee, PhD; Phone Number: 2 6177954947; Email: ClinicalAffairs@ovation.io

Study Locations

• United States
  • Maine
    • Portland, Maine, United States, 04101
      • Ovation.io
      • Contact: Stephanie Balcaitis; Phone Number: 2 617-795-4947; Email: ClinicalAffairs@ovation.io
      • Contact: Ed Stepanski, PhD; Email: ClinicalAffairs@ovation.io
      • Principal Investigator: Pauline Gee, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults who have an active cancer diagnosis with confirmatory pathology results indicating solid tumor and/or hematologic malignancy

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Individuals who lack the capacity to provide informed consent
• Individuals known to be prisoners at time of biological specimen collection

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	10 years

Collaborators and Investigators

• Sponsor: Ovation.io, Inc.
• Investigators: Study Director: Pauline Gee, PhD, VP, Clinical Affairs, Ovation.io

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 1, 2034

Study Registration Dates

• First Submitted: April 11, 2024
• First Submitted That Met QC Criteria: April 11, 2024
• First Posted (Actual): April 17, 2024

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease
• Other Study ID Numbers: Ovation-23-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing Time Frame: Biological specimens and associated data will be stored indefinitely.
• IPD Sharing Access Criteria: All expert determinations performed under this protocol will be pursuant to a business associate agreement and conducted by an individual who has the relevant education and experience to perform a health information de-identification assessment.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No