NCT06772844Toborzás még nem indult
DYNAMICS-LYNCH:DNA Methylation Analysis in Stool for Screening of Lynch Syndrome-Associated Colorectal Cancer
DNA Methylation Analysis in Stool Samples for Screening of Lynch Syndrome-Associated Colorectal Cancer
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. jan. 15. · Több mint 12 hónapja nem frissült - kérdezd meg a helyszínt, nyitott-e még
Rövid összefoglaló (regiszter, angolul)
Colorectal cancer (CRC) has high incidence and mortality rates globally. Over 1 million new cases are diagnosed annually, and about 600,000 people die from the disease each year. In China, CRC ranks third in incidence and fifth in mortality. Its rates are rising due to lifestyle changes and an aging population. Around 30% of CRC cases have a hereditary component, including familial adenomatous polyposis (FAP) and Lynch syndrome. Lynch syndrome, or hereditary non-polyposis colorectal cancer (HNPCC), accounts for 3%-5% of CRC cases. Early diagnosis, screening, and prophylactic surgery can reduce CRC mortality by 7%-42%, and mortality from endometrial and ovarian cancers by 1%-6%. Intensive screening is essential for Lynch syndrome patients, who are at high risk for CRC. Due to the lack of early symptoms, many CRC cases are diagnosed in later stages, causing financial strain on patients, families, and society. Screening is an effective tool in reducing CRC-related mortality by more than 50%. In developed countries such as the U.S., U.K., and Japan, CRC screening is integrated into public health programs, emphasizing its role in prevention. In China, CRC screening mainly involves the fecal occult blood test followed by colonoscopy, but this method faces challenges. First, the fecal occult blood test lacks sufficient sensitivity, leading to underdiagnosis. Second, colonoscopy is invasive with low patient acceptance. It also requires specialized facilities, advanced equipment, and skilled endoscopists, limiting its accessibility. Given China's large population and limited healthcare resources, universal colonoscopy screening is challenging, resulting in low screening rates. To address these challenges, we propose replacing part of colonoscopy screening with DNA methylation testing of fecal samples. Self-sampling methylation screening could ease the strain on healthcare resources and improve patient compliance. By combining methylation screening with colonoscopy, we aim to reduce colonoscopy frequency and enhance overall compliance. This study will include three rounds of methylation screening with colonoscopy as the control, involving 400 Lynch syndrome patients. The goal is to develop new screening criteria for this high-risk group, reduce colonoscopy frequency, and ultimately lower CRC incidence in Lynch syndrome patients.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 400 (tervezett)
- Első benyújtás
- 2025. jan. 10.
- Kezdés
- 2025. jan. 10.
- Elsődleges befejezés
- 2028. jún. 30.
- Fő szponzor
- Sun Yat-sen University
- Betegségek
- Gyermekkori daganatok, Vastagbélrák
- NCT-szám
- NCT06772844
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Tervezett résztvevők: 400
- 2025. jan. 10. és az elsődleges befejezés (2028. jún. 30.) között
- Nincs megadott helyszín, ország nélkül
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
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Más betegség
- Patients with confirmed familial adenomatous polyposis or other hereditary colorectal cancers that are not Lynch syndrome;Patients who are unable to obtain a fecal specimen or whose specimen is substandard for follow-up testing;Patients diagnosed with colorectal cancer or currently undergoing surgery;Failure to sign informed consent
Kiket keres a vizsgálat
- Informed consent: patients are required to participate voluntarily and sign an informed consent form in writing;Patients diagnosed with Lynch syndrome;Agree to collect and send stool specimens for methylation sequencing as required;Willingness to undergo long-term follow-up and three rounds of methylation screening
Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.