Endocrine Disrupting Chemical Exposure and Testicular Cancer

NCT04848545 | Active Not Recruiting DMC

• 1 other identifier: 1R01CA236816-01A1
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 2

Brief Summary

DISRUPT is a Danish nested case-control study that is currently being conducted to explore the impact of prenatal exposure to endocrine disrupting chemicals on testicular cancer risk (including histological sub-groups) with emphasis on the analysis of exposure mixtures. Pregnant mothers provided serum and amniotic fluid at recruitment up to 50 years ago. By registry linkage within highly reliable national population and disease registries cancer cases and matched controls will be identified. Levels of EDCs including DDT, DDE and other organochlorine pesticides, PCBs, PBDEs, PFAS, phthalates and triclosan will be quantified in cases whose sons develop testicular cancer during 40 year follow up and compared to controls.

Conditions

Testicular Cancer

Outcome Measures

Primary Outcomes (1)

• Risk of testicular Cancer (ICD-10 code)

  Ascertained in adult men - Registry based on ICD-10 codes for testicular cancer (C62\*)

  Testicular cancer is ascertained in live-born sons within the cohort, during the follow-up period (up to 50 years)

Study Arms (1)

Live-born sons (with and without testicular cancer diagnosis) from a Danish pregnancy Cohort

Pregnancy cohort: Biological samples from 128,702 of pregnant women were stored for research purposes in the Danish National Biobank, in the period from 1976-2004. Present study: live-born sons (with/without testicular cancer ascertained via data linkage in the Danish Cancer Registry)

Other: Observational

Interventions

Observational OTHER

Prenatal maternal exposure to endocrine disrupting chemicals

Live-born sons (with and without testicular cancer diagnosis) from a Danish pregnancy Cohort

Eligibility Criteria

• Age: 15 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

In Denmark all women, in the first trimester of their pregnancy, are offered a free screen for congenital diseases and chromosomal defects in offspring. According to informed consent from 128,702 of the pregnant women screened in the period from 1976-2004, serum samples from these routine screens were stored the Danish National Biobank. In addition, all live born children (including all sons born to these women) in Denmark are sampled 7 days after birth for heel-blood. The heel blood is sampled as a nationwide screen for congenital diseases and all mothers have provided informed consent to storage. All live-born sons, born to these women will be identified using the CPR-number of each mother that provided a blood sample and extracting data from the Danish Medical Birth registry.

You may qualify if:

• Male
• Available stored maternal serum and/or maternal amniotic fluid

You may not qualify if:

• other cancer

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (2)

Department of Growth and Reproduction, Rigshospitalet

Copenhagen, 2100, Denmark

Location

EDMaRC, Rigshospitalet secton 5064

Copenhagen, 2100, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Amniotic fluid, blood serum and dried heel blood

MeSH Terms

Conditions

Testicular Neoplasms

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Endocrine System Diseases; Testicular Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Anders Juul, PhD, MD

  Vækst og Reproduktion, Rigshospitalet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department of Growth and Reproduction

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: April 19, 2021
• Study Start: June 1, 2020
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030
• Last Updated: April 21, 2021

Record last verified: 2021-04

Locations

DK (2)