NCT05412628 - 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)

Lagergren J, Smyth E, Cunningham D, Lagergren P
Oesophageal cancer. Lancet. 2017 Nov 25;390(10110):2383-2396. doi: 10.1016/S0140-6736(17)31462-9. Epub 2017 Jun 22.
Lee KD, Wang TY, Lu CH, Huang CE, Chen MC
The bidirectional association between oral cancer and esophageal cancer: A population-based study in Taiwan over a 28-year period. Oncotarget. 2017 Jul 4;8(27):44567-44578. doi: 10.18632/oncotarget.17818.
Lin EW, Karakasheva TA, Hicks PD, Bass AJ, Rustgi AK
The tumor microenvironment in esophageal cancer. Oncogene. 2016 Oct 13;35(41):5337-5349. doi: 10.1038/onc.2016.34. Epub 2016 Feb 29.
Peters BA, Wu J, Pei Z, Yang L, Purdue MP, Freedman ND, Jacobs EJ, Gapstur SM, Hayes RB, Ahn J
Oral Microbiome Composition Reflects Prospective Risk for Esophageal Cancers. Cancer Res. 2017 Dec 1;77(23):6777-6787. doi: 10.1158/0008-5472.CAN-17-1296.
Snider EJ, Compres G, Freedberg DE, Khiabanian H, Nobel YR, Stump S, Uhlemann AC, Lightdale CJ, Abrams JA
Alterations to the Esophageal Microbiome Associated with Progression from Barrett's Esophagus to Esophageal Adenocarcinoma. Cancer Epidemiol Biomark
Yang L, Francois F, Pei Z
Molecular pathways: pathogenesis and clinical implications of microbiome alteration in esophagitis and Barrett esophagus. Clin Cancer Res. 2012 Apr 15;18(8):2138-44. doi: 10.1158/1078-0432.CCR-11-0934. Epub 2012 Feb 16.
Zhou J, Sun S, Luan S, Xiao X, Yang Y, Mao C, Chen L, Zeng X, Zhang Y, Yuan Y
Gut Microbiota for Esophageal Cancer: Role in Carcinogenesis and Clinical Implications. Front Oncol. 2021 Oct 18;11:717242. doi: 10.3389/fonc.2021.717242. eCollection 2021.

Investigating the Association, Disease Mechanism, and Clinical Application Between Microbiota and Oropharyngeal and Esophageal Cancer

Details for clinical trial NCT05412628

Clinical trial NCT05412628 - References