Kalıtsal ve Yüksek Riskli Kanserlerde cfDNA 2

Sade dilde özet

Bu çalışma, kalıtsal kanser sendromları taşıyan ya da yüksek kanser riski olan kişilerde, kandan alınan hücre dışı DNA (cell-free DNA) analizini değerlendiriyor. Çalışmaya, kalıtsal meme ve yumurtalık kanseri (hereditary breast and ovarian cancer), Lynch sendromu (Lynch Syndrome), Nörofibromatozis tip I (Neurofibromatosis type I), Li-Fraumeni sendromu (Li-Fraumeni Syndrome), PALB2 ve kalıtsal yaygın mide kanseri (Hereditary Diffuse Gastric Cancer) gibi tanıları olan kişiler katılabiliyor. Faz uygulanmayan bir çalışma olup halen katılımcı almaktadır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

N/A

Durum

Katılımcı alıyor

Sponsor

University Health Network, Toronto

Müdahale

Cell-free DNA analysis

Başlangıç

19.04.2024

Tahmini bitiş

01.12.2031

Ülkeler

Canada

İlgili genler

Merkezler

• Vancouver, Canada
• St. John's, Canada
• Halifax, Canada
• Toronto, Canada
• Toronto, Canada
• Toronto, Canada
• Toronto, Canada
• Montreal, Canada

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

Inclusion Criteria:

* Patients with a confirmed diagnosis of hereditary breast and ovarian cancer (HBOC), Lynch Syndrome (LS), Neurofibromatosis type I (NF1), Li-Fraumeni Syndrome (LFS), PALB2, and Hereditary Diffuse Gastric Cancer (HDGC), (i.e., patients with an identified pathogenic variant in the respective cancer predisposition gene, or patients with uninformative genetic testing but with a family history suggestive of the cancer predisposition syndrome).
* Patients must be receiving standard-of-care clinical assessment for cancer by a managing physician under a provincial screening program or cancer surveillance protocol.
* All patients must have signed and dated an informed consent form for this study.

Exclusion Criteria:

* Patients must not have a personal history of cancer diagnosed and treated within 3 years prior to the expected first sample collection date for this study. If a patient has a personal history of cancer, treatment must have been completed successfully at least 3 years prior to first study sample collection.
* Patients diagnosed more than 3 years prior to the expected first sample collection date, but never been treated for the cancer.
* Patients undergoing investigations for a clinical suspicion of cancer.
* Patients who are not able to comply with the protocol (i.e., tri-annual blood sample collection if randomized into the experimental cohort).