cfMeDIP-seq Assay Prospective Observational Validation for Early Cancer Detection and Minimal Residual Disease (CAMPERR)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT05366881 |
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Recruitment Status :
Recruiting
First Posted : May 9, 2022
Last Update Posted : June 21, 2022
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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 four cancer types (breast, colorectal, lung, prostate). These cancers were selected based on the existing clinical landscape and treatment availability.
| Condition or disease |
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| Brain Cancer Breast Cancer Bladder Cancer Cervical Cancer Colorectal Cancer Endometrial Cancer Esophageal Cancer Stomach Cancer Head and Neck Cancer Hepatobiliary Cancer Leukemia Lung Cancer Lymphoma Multiple Myeloma Ovarian Cancer Pancreatic Cancer Prostate Cancer Renal Cancer Sarcoma Thyroid Cancer |
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 breast, colorectal, lung, or prostate 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 will 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 Type : | Observational |
| Estimated Enrollment : | 5280 participants |
| Observational Model: | Case-Control |
| Time Perspective: | Prospective |
| Official Title: | cfMeDIP-seq Assay Multicenter Prospective Observational Validation for Early Cancer Detection, Minimal Residual Disease, and Relapse |
| Actual Study Start Date : | May 3, 2022 |
| Estimated Primary Completion Date : | December 2023 |
| Estimated Study Completion Date : | December 2026 |
| Group/Cohort |
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Cases
Cases will include participants with newly diagnosed, treatment-naive cancer at the time of enrollment.
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Controls
Controls will include participants without known cancer at the time of enrollment.
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- 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
- Detection of specific cancer types [ Time Frame: 24 months ]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
- Tissue of origin [ Time Frame: 18 months ]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
- Clinical outcomes [ Time Frame: 54 months ]Recurrence-free survival and overall survival among cancer cases
Biospecimen Retention: Samples With DNA
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Case Inclusion Criteria:
- Newly diagnosed (within 90 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05366881
| Contact: Brian Allen, MS | 203-514-4155 | brian.allen@adelabio.com | |
| Contact: Michelle Anderson | 475-766-8183 | michelle.anderson@adelabio.com |
| United States, California | |
| City of Hope | Recruiting |
| Duarte, California, United States, 91010 | |
| Contact: Xiao-Yu Xia 626-218-0630 xxia@coh.org | |
| Principal Investigator: Gregory Idos, MD | |
| United States, Ohio | |
| Cleveland Clinic | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
| Contact: Mofetoluwa Oluwasanmi 216-444-0843 oluwasm@ccf.org | |
| Principal Investigator: Peter Mazzone, MD, MPH | |
| United States, Tennessee | |
| Vanderbilt-Ingram Cancer Center | Recruiting |
| Nashville, Tennessee, United States, 37203 | |
| Contact: Anna Dumont anna.dumont@vumc.org | |
| Principal Investigator: Brian Rini, MD | |
| Principal Investigator: | Brian Rini, MD | Vanderbilt-Ingram Cancer Center |
| Responsible Party: | Adela, Inc. |
| ClinicalTrials.gov Identifier: | NCT05366881 |
| Other Study ID Numbers: |
Adela-EDMRD-001 |
| First Posted: | May 9, 2022 Key Record Dates |
| Last Update Posted: | June 21, 2022 |
| Last Verified: | June 2022 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Multi-cancer early detection Liquid Biopsy Methylome Cancer screening cell-free DNA |
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Multiple Myeloma Endometrial Neoplasms Neoplasm, Residual Brain Neoplasms Kidney Neoplasms Stomach Neoplasms Urogenital Neoplasms Neoplasms by Site Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases Neoplasms, Plasma Cell Neoplasms by Histologic Type |
Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Genital Neoplasms, Female Uterine Neoplasms Uterine Diseases Urologic Neoplasms Urologic Diseases |