NCT05366881 cfDNA Assay Prospective Observational Validation for Early Cancer Detection and Minimal Residual Disease
| NCT ID | NCT05366881 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Adela, Inc |
| Condition | Brain Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 7,000 participants |
| Start Date | 2022-05-03 |
| Primary Completion | 2026-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 7,000 participants in total. It began in 2022-05-03 with a primary completion date of 2026-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is an observational case-control study to train and validate a genome-wide methylome enrichment platform to detect multiple cancer types and to differentiate amongst cancer types. The cancers included in this study are brain, breast, bladder, cervical, colorectal, endometrial, esophageal, gastric, head and neck, hepatobiliary, leukemia, lung, lymphoma, multiple myeloma, ovarian, pancreatic, prostate, renal, sarcoma, and thyroid. These cancers were selected based on their prevalence and mortality to maximize impact on clinical care. Additionally, the ability of the whole-genome methylome enrichment platform to detect minimal residual disease after completion of cancer treatment and to detect relapse prior to clinical presentation will be evaluated in lung cancer. This cancer was selected based on the existing clinical landscape and treatment availability.
Eligibility Criteria
Case Inclusion Criteria: * Newly diagnosed (within 120 days) with cancer or a recurrence of a cancer diagnosed \>5 years ago of one of the following subtypes: Invasive Brain, Breast, Bladder, Cervical, Colorectal, Endometrial, Esophageal, Gastric, Head and Neck, Hepatobiliary, Lung, Ovarian, Pancreatic, Prostate, Renal, Sarcoma, Thyroid; Leukemia, Lymphoma, Multiple Myeloma * Able and willing to provide informed consent * ≥40 years of age Case Exclusion Criteria: * Currently receiving any treatment for cancer * Currently taking any demethylating agents/DNA hypomethylating agents * Simultaneously diagnosed with two or more invasive cancers * Diagnosed with any invasive or non-invasive cancer in addition to the index cancer in the last 5 years * Currently diagnosed with any chronic hematopoietic cancer (e.g. chronic CLL) in addition to the index cancer * Currently diagnosed with any myelodysplastic syndromes and/or precursor hematologic conditions (e.g. MGUS) in addition to the index cancer * Women who are known to be pregnant (self-reported) Control Inclusion Criteria * Not diagnosed with any cancer in the last 5 years (non-invasive cancer is allowed) * Able and willing to provide informed consent * ≥40 years of age Control Exclusion Criteria * Currently receiving any treatment for cancer * Currently taking any demethylating agents/DNA hypomethylating agents * Women who are known to be pregnant (self-reported)
Contact & Investigator
Brian Rini, MD
PRINCIPAL INVESTIGATOR
Vanderbilt-Ingram Cancer Center
Frequently Asked Questions
Who can join the NCT05366881 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Brain Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05366881 currently recruiting?
Yes, NCT05366881 is actively recruiting participants. Contact the research team at brian.allen@adelabio.com for enrollment information.
Where is the NCT05366881 trial being conducted?
This trial is being conducted at Duarte, United States, Miami, United States, Gainesville, United States, New Albany, United States and 11 additional locations.
Who is sponsoring the NCT05366881 clinical trial?
NCT05366881 is sponsored by Adela, Inc. The principal investigator is Brian Rini, MD at Vanderbilt-Ingram Cancer Center. The trial plans to enroll 7,000 participants.
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