NCT06369441

Brief 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. Future studies may use stored blood samples to discover how genes affect health and disease.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
96mo left

Started Apr 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress21%
Apr 2024Apr 2034

Study Start

First participant enrolled

April 1, 2024

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

April 11, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 17, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2034

Expected
Last Updated

April 17, 2024

Status Verified

April 1, 2024

Enrollment Period

1 year

First QC Date

April 11, 2024

Last Update Submit

April 11, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Oncology

Adults (aged 18 or older) who have an active cancer diagnosis with confirmatory pathology results indicating solid tumor and/or hematologic malignancy.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ovation.io

Portland, Maine, 04101, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole Blood

MeSH Terms

Conditions

NeoplasmsDisease

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Pauline Gee, PhD

    VP, Clinical Affairs, Ovation.io

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2024

First Posted

April 17, 2024

Study Start

April 1, 2024

Primary Completion

April 1, 2025

Study Completion (Estimated)

April 1, 2034

Last Updated

April 17, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, ICF, CSR
Time Frame
Biological specimens and associated data will be stored indefinitely.
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.

Locations