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NCT06584994Enrolling by invitation

Investigating the Role of Genetics in Disease Predisposition

Investigating Clonal Dynamics in Gonads and Their Role in Disease Predisposition

Source: ClinicalTrials.gov · Last updated 5 Sept 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

Gametogenesis is the production of sperm and eggs; it takes place through the process of meiosis. Gametogenesis is subject to the acquisition of mutations as with other processes in the body. Many of these mutations are somatic, meaning that they occur during life as part of the process of cell division rather than being passed down from parents. When somatic mutations take place during gametogenesis, there is the potential for hereditary genetic consequences. However, the processes that cause the mutations during gametogenesis and the implications they have for heritability and disease predisposition are poorly understood. The goal of this research is to provide a detailed description of the genetic changes in gonadal tissues, and to understand how mutations acquired during the production of germ cells (sperm and eggs) contribute to the predisposition to a wide range of rare diseases and cancer predisposition in future offspring.

Status (registry)
Enrolling by invitation
Study type
Observational
Enrollment
1000 (estimated)
First submitted
4 Jul 2024
Start date
20 Jun 2021
Primary completion date
1 Mar 2027
Lead sponsor
The Wellcome Sanger Institute
NCT number
NCT06584994

What you commit to

  • Study type: Observational
  • Planned participants: 1000
  • From 20 Jun 2021 to the primary completion date, 1 Mar 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

  • Minimum of child affected with cancer pre-disposition syndromes and their father
  • Additional family members of consented father and child duos (Mother, same parent siblings, Maternal/Paternal Aunts, uncles and grandparents of affected child)
  • Reproductive tissue samples from both men and women affected by cancer collected with consent for use in research.
  • Reproductive tissue samples from both men and women unaffected by cancer collected with consent for use in research.
    • Exclusion:
  • Fathers who do not wish to donate a semen sample or are unable to will be excluded from the study, as will their families
  • Fathers who have had a vasectomy will be excluded from the study as will their families
  • Adults who do not have the capacity to consent for themselves will be excluded from the study.
  • Families in which both parents do not have capacity to consent will also be excluded as they will be unable to give parental consent for their children's participation.
  • In order to be eligible siblings must share the same two parents as the affected child, all other siblings will be excluded from the study.
  • Male relatives in the extended family (Maternal/Paternal Aunts, uncles and grandparents of affected child) unwilling or unable to donate both a blood or saliva sample and a semen sample will be excluded from the study.
  • Participants who do not have a good understanding of the English language will be excluded from the study.

Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Wellcome Sanger Institute
Coordinator of this site? Confirm its status
CambridgeUnited KingdomUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.