NCT03828396 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

1
Shaukat A, Mongin SJ, Geisser MS, et al. Long-term mortality after screening for colorectal cancer. N Engl J Med, 2013; 369(12): 1106-1114. 2. Brenner H, Tao S. Superior diagnostic performance of faecal immunochemical tests for haemoglobin in a head-to-head comparison with guaiac based faecal occult blood test among 2235 participants of screening colonoscopy. Eur J Cancer, 2013, 49(14): 3049-3054. 3. National Cancer Institute's SEER database. [EB/OL]. http://seer.cancer.gov/. Accessed August 26, 2016. 4. M. Esteller. Molecular origins of cancer: epigenetics in cancer. New Engl J Med, 2008; 358(11): 1148-1096. 5. D. J. Weisenberger, K. D. Siegmund, et al. CpG island methylator phenotype underlies sporadic microsatellite instability and is tightly associated with BRAF mutation in colorectal cancer. Nature Genetics, 2006; 38(7): 787-793. 6. E. E. Torlakovic, J. D. Gomez, et al. Sessile serrated adenoma(SSA) vs traditional serrated adenoma(TSA). American Journal of Surgical Pathology, 2008; 32(1): 21-29. 7. Hironori Aoki, Eiichiro Yamamoto, et al. Epigenetic silencing of SMOC1 in traditional serrated adenoma and colorectal cancer. Oncotarget, 2018; 9(4): 4707-4721. 8. Genetic/Familial High-Risk Assessment: Colorectal. NCCN Guidelines. Version 3. 2017.

Non-invasive Auxiliary Diagnosis of Colorectal Cancer and Advanced Adenoma by Detecting Cancer-specific Methylation Signatures in Plasma ctDNA

Clinical trial NCT03828396 - References