Cancer, Treatment-RelatedNCT06587477
Testicular Function and Semen Quality in Male Childhood and Adolescent Cancer Survivors
An observational study of Cancer, Treatment-Related and Late Effect, run by The University of Hong Kong at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Cancer, Treatment-Related, Late Effect, Semen Analysis
- What is being tested?
- Hormonal profile, Semen analysis and Questionnaire
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 16 Jan 2023to 30 Jun 2028
- How long will I take part?
- 3 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- No healthy volunteers
- Adult
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
Who may be able to join
- 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
Who cannot join
- Unable to ejaculate by masturbation to provide semen samples
- Cryptorchidism, testicular cancer, history of vasectomy
- On testosterone replacement therapy
- Refusal to join the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Queen Mary Hospital
Hong Kong
Jennifer Ko, 22554647, jenko@hku.hk
About this study
Official title: Effect of Cancer Treatment on Testicular Function and Semen Quality in Male Childhood and Adolescent Cancer Survivors
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.
Read the detailed description
This is a cohort observational study. 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, currently > 18 years old to 50 years old and cancer in remission for at least 2 years. The testicular function, including sperm and hormonal functions, will be compared with aged-matched controls from men attending the Family Planning Association for premarital check-up.
- Conditions
- Cancer, Treatment-Related, Late Effect, Semen Analysis
- Being tested
- Hormonal profile, Semen analysis, Questionnaire
- Keywords
- cancer treatment, testicular function, semen quality, cancer survivors
- Medical subject headings
- Neoplasms, Second Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hormonal profileOther
Blood for FSH, LH, testosterone
Semen analysisOther
Semen analysis
QuestionnaireOther
The European Male Ageing Study (EMAS) questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Male childhood and adolescent cancer survivors | Male childhood and adolescent cancer survivors Receives: Other: Hormonal profile; Other: Semen analysis; Other: Questionnaire | |
| Controls | Aged-matched controls from men attending the Family Planning Association for premarital check-up Receives: Other: Hormonal profile; Other: Semen analysis; Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sperm concentration
Sperm concentration
Measured: up to 3 months
Secondary outcomes (1)
Semen parameters
Based on the WHO criteria
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start16 Jan 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer, Treatment-RelatedStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 3 Weeks
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Queen Mary Hospital, Hong Kong, Prince of Wales Hospital, Shatin, Hong Kong, Hong Kong Children's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06587477
- Sponsor's protocol ID
- UW21-038
- Status last verified
- May 2024
- First submitted
- 13 May 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cancer Treatment on Testicular Function and Semen Quality in Male Childhood and Adolescent Cancer Survivors
- ClinicalTrials.gov ID
- NCT06587477
- Acronym / sponsor ID
- UW21-038
- Conditions
- Cancer, Treatment-Related, Late Effect, Semen Analysis
- Keywords
- cancer treatment, testicular function, semen quality, cancer survivors
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Queen Mary Hospital, Hong Kong, Prince of Wales Hospital, Shatin, Hong Kong, Hong Kong Children's Hospital
- Study start
- 16 Jan 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a cohort observational study. 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, currently > 18 years old to 50 years old and cancer in remission for at least 2 years. The testicular function, including sperm and hormonal functions, will be compared with aged-matched controls from men attending the Family Planning Association for premarital check-up.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Male childhood and adolescent cancer survivors | – | Other: Hormonal profile, Other: Semen analysis, Other: QuestionnaireMale childhood and adolescent cancer survivors |
| Controls | – | Other: Hormonal profile, Other: Semen analysis, Other: QuestionnaireAged-matched controls from men attending the Family Planning Association for premarital check-up |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Unable to ejaculate by masturbation to provide semen samples
- Cryptorchidism, testicular cancer, history of vasectomy
- On testosterone replacement therapy
- Refusal to join the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hormonal profileBlood for FSH, LH, testosterone | Other | Controls, Male childhood and adolescent cancer survivors |
| Semen analysisSemen analysis | Other | Controls, Male childhood and adolescent cancer survivors |
| QuestionnaireThe European Male Ageing Study (EMAS) questionnaire | Other | Controls, Male childhood and adolescent cancer survivors |
Primary outcome
Sperm concentration
Time frame: up to 3 months
Sperm concentration
1 secondary outcome
Semen parameters
Time frame: up to 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, Treatment-Related and Late Effect, run by The University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Ko (22554647, jenko@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sperm concentration (time frame: up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.