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Clinical 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. 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.


Clinical Trial 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 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 Design


Related Conditions & MeSH terms

  • Bladder Cancer
  • Brain Cancer
  • Brain Neoplasms
  • Breast Cancer
  • Cervical Cancer
  • Colorectal Cancer
  • Endometrial Cancer
  • Endometrial Neoplasms
  • Esophageal Cancer
  • Head and Neck Cancer
  • Hepatobiliary Cancer
  • Kidney Neoplasms
  • Leukemia
  • Lung Cancer
  • Lymphoma
  • Multiple Myeloma
  • Neoplasm, Residual
  • Ovarian Cancer
  • Pancreatic Cancer
  • Prostate Cancer
  • Renal Cancer
  • Sarcoma
  • Stomach Cancer
  • Stomach Neoplasms
  • Thyroid Cancer

NCT number NCT05366881
Study type Observational
Source Adela, Inc.
Contact Brian Allen, MS
Phone 203-514-4155
Email [email protected]
Status Not yet recruiting
Phase
Start date May 2022
Completion date December 2026

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