Brain CancerCAMPERRNCT05366881
cfDNA Assay Prospective Observational Validation for Early Cancer Detection and Minimal Residual Disease
An observational study of Brain Cancer and Breast Cancer, run by Adela, Inc at 17 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Brain Cancer, Breast Cancer, Bladder Cancer
- How many people
- 7,000 participants
- Where
- 17 sitesUnited States
- Study dates
- 3 May 2022to Dec 2027
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study will enroll individuals with newly diagnosed cancer as cancer cases and individuals without known cancer as controls. Participants will be enrolled from sites across the United States.
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)
Trial locations and contacts
17 sites in 1 country. Contact the study team or a site near you to ask about taking part.
17 sites in 1 country
United States17 sites, 3 recruiting
- Completed
Elligo Health Research, Inc.
Austin, Texas, 78704
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Michael Balassone, 843-792-6696, balassom@musc.edu
Andrew M Chen, chenand@musc.edu
- Completed
Cleveland Clinic
Cleveland, Ohio, 44195
- Completed
Baptist Corbin
Corbin, Kentucky, 40701
- Recruiting
City of Hope
Duarte, California, 91010
Xiao-Yu Xia, 626-218-0630, xxia@coh.org
Gregory Idos, MD
- Completed
Baptist Hardin
Elizabethtown, Kentucky, 42701
- Completed
McLeod Health
Florence, South Carolina, 29502
- Completed
North Georgia Health System
Gainesville, Georgia, 306501
- Completed
Baptist Lexington
Lexington, Kentucky, 40503
- Completed
Baptist (BHMCC)
Memphis, Tennessee, 38120
- Completed
Miami Cancer Institute
Miami, Florida, 33176
- Completed
Allina Health Cancer Institute
Minneapolis, Minnesota, 55407
- Completed
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37203
- Completed
Baptist Floyd
New Albany, Indiana, 47150
- Withdrawn
Baptist Paducah
Paducah, Kentucky, 42003
- Recruiting
Oregon Health Sciences University
Portland, Oregon, 97201
Diana Potts, pottsd@ohsu.edu
Nima Nabavizadeh, MD
- Completed
Mayo Clinic
Rochester, Minnesota, 55902
About this study
Official title: cfDNA Assay Multicenter Prospective Observational Validation for Early Cancer Detection, Minimal Residual Disease, and Relapse
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.
Read the detailed description
This is an observational case-control study that includes individuals with cancer and individuals without known cancer. All participants will have clinical follow-up after enrollment. A subset of individuals with cancer will also have longitudinal blood sampling to evaluate the ability of the genome-wide methylome enrichment platform to detect minimal residual disease. This includes individuals with Stage I-III lung cancer (Tier 1 Cancers).
At baseline, all participants will provide a blood sample and applicable clinical data.
Participants with a Tier 1 cancer will have clinical follow-up and blood draws after the completion of first-line treatment, every 3 months for the first year after first-line treatment, and every 6 months for an additional 2 years. All other cases may have clinical follow-up once a year for 3 years after enrollment.
Control participants will have clinical follow-up every 6 months for up to 3 years from enrollment to evaluate cancer status.
The blood test to be used in this study is a highly sensitive, epigenomic-based genome-wide methylome enrichment platform. The assay includes bisulfite-free, non-degradative genome-wide DNA methylation profiling from small quantities of cell-free DNA (cfDNA). Libraries constructed from cfDNA are enriched for methylated CpGs and preserve the native fragment length. This is followed by high throughput sequencing.
For all assays, samples from participants with cancer and participants without cancer will be run together to reduce batch effects using methodology determined by the Sponsor. Results from the liquid biopsy test will not be returned to clinicians or participants.
- Conditions
- Brain Cancer, Breast Cancer, Bladder Cancer, Cervical Cancer, Colorectal Cancer, Endometrial Cancer
- Keywords
- Multi-cancer early detection, Liquid Biopsy, Methylome, Cancer screening, cell-free DNA
- Medical subject headings
- Brain Neoplasms, Breast Neoplasms, Urinary Bladder Neoplasms, Uterine Cervical Neoplasms, Colorectal Neoplasms, Endometrial Neoplasms, Esophageal Neoplasms, Stomach 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 |
|---|---|---|
| Cases | Cases will include participants with newly diagnosed, treatment-naive cancer at the time of enrollment. | |
| Controls | Controls will include participants without known cancer at the time of enrollment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of cancer
Differentiation of cancer signals from cases and non-cancer signals from controls based on analysis of cfDNA using the genome-wide methylome enrichment platform
Measured: 24 months
Secondary outcomes (3)
Detection of specific cancer types
Differentiation of cancer signals from cases with a specific cancer type and non-cancer signals from controls based on analysis of cfDNA using the genome-wide methylome enrichment platform
Measured: 24 months
Tissue of origin
Identification of the correct tissue of origin (as determined by clinical diagnosis) for cancer cases based on analysis of cfDNA using the genome-wide methylome enrichment platform
Measured: 18 months
Clinical outcomes
Recurrence-free survival and overall survival among cancer cases
Measured: 54 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2022
- Study start3 May 2022
- Primary completion31 Dec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain 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-control
- Time perspective
- Prospective
- Enrolment
- 7,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adela, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brian Rini, MD, Principal investigator, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05366881
- Sponsor's protocol ID
- Adela-EDMRD-001
- Acronym
- CAMPERR
- Status last verified
- Nov 2026
- First submitted
- 3 May 2022
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- cfDNA Assay Multicenter Prospective Observational Validation for Early Cancer Detection, Minimal Residual Disease, and Relapse
- ClinicalTrials.gov ID
- NCT05366881
- Acronym / sponsor ID
- CAMPERR / Adela-EDMRD-001
- Conditions
- Brain Cancer, Breast Cancer, Bladder Cancer, Cervical Cancer, Colorectal Cancer, Endometrial Cancer
- Keywords
- Multi-cancer early detection, Liquid Biopsy, Methylome, Cancer screening, cell-free DNA
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 7,000 participants (estimated)
- Lead sponsor
- Adela, IncIndustry (pharma, biotech, devices)
- Study start
- 3 May 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 9 May 2022 (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.
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.
Detailed description
This is an observational case-control study that includes individuals with cancer and individuals without known cancer. All participants will have clinical follow-up after enrollment. A subset of individuals with cancer will also have longitudinal blood sampling to evaluate the ability of the genome-wide methylome enrichment platform to detect minimal residual disease. This includes individuals with Stage I-III lung cancer (Tier 1 Cancers).
At baseline, all participants will provide a blood sample and applicable clinical data.
Participants with a Tier 1 cancer will have clinical follow-up and blood draws after the completion of first-line treatment, every 3 months for the first year after first-line treatment, and every 6 months for an additional 2 years. All other cases may have clinical follow-up once a year for 3 years after enrollment.
Control participants will have clinical follow-up every 6 months for up to 3 years from enrollment to evaluate cancer status.
The blood test to be used in this study is a highly sensitive, epigenomic-based genome-wide methylome enrichment platform. The assay includes bisulfite-free, non-degradative genome-wide DNA methylation profiling from small quantities of cell-free DNA (cfDNA). Libraries constructed from cfDNA are enriched for methylated CpGs and preserve the native fragment length. This is followed by high throughput sequencing.
For all assays, samples from participants with cancer and participants without cancer will be run together to reduce batch effects using methodology determined by the Sponsor. Results from the liquid biopsy test will not be returned to clinicians or participants.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | –Cases will include participants with newly diagnosed, treatment-naive cancer at the time of enrollment. |
| Controls | – | –Controls will include participants without known cancer at the time of enrollment. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study will enroll individuals with newly diagnosed cancer as cancer cases and individuals without known cancer as controls. Participants will be enrolled from sites across the United States.
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
Detection of cancer
Time frame: 24 months
Differentiation of cancer signals from cases and non-cancer signals from controls based on analysis of cfDNA using the genome-wide methylome enrichment platform
3 secondary outcomes
Detection of specific cancer types
Time frame: 24 months
Tissue of origin
Time frame: 18 months
Clinical outcomes
Time frame: 54 months
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 4 Nov 2026.
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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.
Brian Rini, MD principal investigator
Vanderbilt-Ingram Cancer Center
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Cancer and Breast Cancer, run by Adela, Inc at 17 sites 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?
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: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites 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 Brian Allen, MS (203-514-4155, brian.allen@adelabio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of cancer (time frame: 24 months). 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 4 Nov 2026.