cfMeDIP-seq Assay Prospective Observational Validation for Early Cancer Detection and Minimal Residual Disease (CAMPERR)
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|ClinicalTrials.gov Identifier: NCT05366881|
Recruitment Status : Recruiting
First Posted : May 9, 2022
Last Update Posted : June 21, 2022
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|
|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|
|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|
Cases will include participants with newly diagnosed, treatment-naive cancer at the time of enrollment.
Controls will include participants without known cancer at the time of enrollment.
- 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
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, MSfirstname.lastname@example.org|
|Contact: Michelle Andersonemail@example.com|
|United States, California|
|City of Hope||Recruiting|
|Duarte, California, United States, 91010|
|Contact: Xiao-Yu Xia 626-218-0630 firstname.lastname@example.org|
|Principal Investigator: Gregory Idos, MD|
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|Contact: Mofetoluwa Oluwasanmi 216-444-0843 email@example.com|
|Principal Investigator: Peter Mazzone, MD, MPH|
|United States, Tennessee|
|Vanderbilt-Ingram Cancer Center||Recruiting|
|Nashville, Tennessee, United States, 37203|
|Contact: Anna Dumont firstname.lastname@example.org|
|Principal Investigator: Brian Rini, MD|
|Principal Investigator:||Brian Rini, MD||Vanderbilt-Ingram Cancer Center|