NCT06587477

Brief Summary

Cancer treatment can affect the testicular function, including sperm and hormonal functions. The aim of this study is to assess the testicular function and semen quality in young men who recover from childhood and adolescent cancer in Hong Kong. This can provide more information for pre-treatment counselling as well as improve post treatment survivorship care. The testicular function will be compared to aged-matched controls from men attending the Family Planning Association for premarital check-up.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
26mo left

Started Jan 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress61%
Jan 2023Jun 2028

Study Start

First participant enrolled

January 16, 2023

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 13, 2024

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Last Updated

September 19, 2024

Status Verified

May 1, 2024

Enrollment Period

5 years

First QC Date

May 13, 2024

Last Update Submit

September 6, 2024

Conditions

Keywords

cancer treatmenttesticular functionsemen qualitycancer survivors

Outcome Measures

Primary Outcomes (1)

  • Sperm concentration

    Sperm concentration

    up to 3 months

Secondary Outcomes (1)

  • Semen parameters

    up to 3 months

Other Outcomes (2)

  • Testicular volume

    up to 3 months

  • Hormonal profile

    up to 3 months

Study Arms (2)

Male childhood and adolescent cancer survivors

Male childhood and adolescent cancer survivors

Other: Hormonal profileOther: Semen analysisOther: Questionnaire

Controls

Aged-matched controls from men attending the Family Planning Association for premarital check-up

Other: Hormonal profileOther: Semen analysisOther: Questionnaire

Interventions

Blood for FSH, LH, testosterone

ControlsMale childhood and adolescent cancer survivors

Semen analysis

ControlsMale childhood and adolescent cancer survivors

The European Male Ageing Study (EMAS) questionnaire

ControlsMale childhood and adolescent cancer survivors

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Target participant Population * The target population for the trial will be men who have received chemotherapy and/ or radiotherapy for cancer diagnosed when they were \< 18 years old. * Aged-matched controls from men attending the Family Planning Association for premarital check-up

You may qualify if:

  • Men who have received chemotherapy and/ or radiotherapy for cancer diagnosed when they were \< 18 years old.
  • \> 18 years old to 50 years old
  • Cancer in remission for at least 2 years

You may not qualify if:

  • Unable to ejaculate by masturbation to provide semen samples
  • Cryptorchidism, testicular cancer, history of vasectomy
  • On testosterone replacement therapy
  • Refusal to join the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Mary Hospital

Hong Kong, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Excess serum for future research use

MeSH Terms

Conditions

Neoplasms, Second Primary

Interventions

Semen AnalysisSurveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesData CollectionEpidemiologic MethodsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Central Study Contacts

Jennifer Ko

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
3 Weeks
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2024

First Posted

September 19, 2024

Study Start

January 16, 2023

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

June 30, 2028

Last Updated

September 19, 2024

Record last verified: 2024-05

Locations