Sperm Count, LowNCT04554030
Impact of Immunotherapy on the Sperm Count of Patients With Cancer
An observational study of Sperm Count, Low, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
Trial summary
Cancer is a public health problem. In recent years, oncology has been revolutionized with the advent of new treatments for different tumor models, mainly immunotherapy directed against cell cycle control points. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Sperm Count, Low
- What is being tested?
- Evaluate sperm count before and after immunotherapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- 1 siteArgentina
- Study dates
- 2 Jan 2020to 30 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Men on treatment with immunotherapy with check point inhibitors for cancer disease.
Who may be able to join
- Diagnosis of cancer with indication for treatment with immunotherapy.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Argentina1 site, 1 recruiting
- Recruiting
Nicolas Minatta
Capital Federal, 1413
Nicolas Minatta, MD, +5491138018573, jose.minatta@hiba.org.ar
Vanesa Kazanietz, MD, +5491149590200, vanesa.kazanietz@hospitalitaliano.org.ar
About this study
Official title: Impact of Immunotherapy in the Spermogram
Cancer is a public health problem. In recent years, oncology has been revolutionized with the advent of new treatments for different tumor models, mainly immunotherapy directed against cell cycle control points. Numerous inhibitory pathways are incorporated into the immune system to maintain tolerance and homeostasis, and these are collectively known as immunological checkpoints.
The main function of immunological checkpoints is to protect tissues from damage when the immune system is responding to pathogens and maintain tolerance to self antigens (ie, prevent autoimmunity). This is mainly achieved by down-regulation of T cell activation or effector functions. There is increasing evidence to show that a primary mechanism by which tumors evade the immune system is through the participation of immunological checkpoints. This has stimulated the development of many novel agents that modulate immunological checkpoints or other costimulatory receptors.
Read more
CTLA-4 is the first receptor of the checkpoint that is successfully selected as immunotherapy. Ipilimumab, an anti-CTLA-4 monoclonal antibody, was the first immunological checkpoint inhibitor to receive FDA approval for the treatment of advanced melanoma.
On the other hand, PD-1 is another receptor for the immune control point, and its ligands, the programmed cell death ligand 1 (PD-L1) and PD-L2, also resulted in important therapeutic advances in cancer immunotherapy.
Unlike CTLA-4, PD-1 is widely expressed and can be found in, in addition to T cells, in B cells and natural killer (NK) cells. The main function of PD-1 is to limit the activity of T cells in peripheral tissues during an inflammatory immune response.
The tumors can exploit this control point, expressing the ligand PD-L1 and generating that the cytotoxic T lymphocytes and the NK cells are anergic and incapable of killing. This up-regulation mechanism of PD-L1 is known in tumors such as melanoma, lung and ovary. Several monoclonal antibodies directed to PD-1 have already received approvals for their clinical use as Nivolumab and Pembrolizumab.
Read the detailed description
The toxic effect of cytostatics (chemotherapy) at the gonadal level is known, but the effect that anti PD-1 immunotherapy can have on the spermogram of oncological patients at the level of the blood-testicular barrier, endocrine axis, among others, is not known. The proinflammatory mechanisms of immunotherapy could incur in damage evidenced as quali-quantitative alterations of the spermogram.
Primary end point:
To evaluate the difference in spermogram (counting, functionality, vitality, mobility) before and after treatment with anti-PD1 immunotherapy first line of oncological treatment of adult patients
Secondary end point:
Evaluate the association adjusted for nutrition, endocrine disorders. Evaluate modifications in the sexual functionality of patients through validated sexuality questionnaires before and during treatment.
In the absence of information, according to the results obtained, cryopreservation prior to the start of treatment could be taken into consideration.
Design: Observational prospective cohort with a single group. With start of follow-up from the oncological diagnosis of patients who are in the process of starting treatment with immunotherapy, checkpoint inhibitors in first line setting. The spermogram samples will be performed: 2 baseline before the start of the drug and +/- 5 days of the start of the treatment, separated by at least 2 weeks. Subsequent samples will be taken 3, 6 and 12 months after the start of treatment.
- Conditions
- Sperm Count, Low
- Being tested
- Evaluate sperm count before and after immunotherapy
- Medical subject headings
- Oligospermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluate sperm count before and after immunotherapyBehavioural
Evaluate sperm count before and after immunotherapy
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the difference in the spermogram before and after immunotherapy exposure
To determine differences in sperm count before and after exposure to immunotherapy. Count measured in cells / mm3
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study start2 Jan 2020
- Primary completion30 Sep 2021 (estimated)
- Study completion30 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sperm Count, LowStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Italiano de Buenos Aires
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JOSE NICOLAS MINATTA, Hospital Italiano de Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04554030
- Sponsor's protocol ID
- 4019
- Status last verified
- Sep 2020
- First submitted
- 2 Jan 2020
- Last updated
- 18 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Immunotherapy in the Spermogram
- ClinicalTrials.gov ID
- NCT04554030
- Acronym / sponsor ID
- 4019
- Conditions
- Sperm Count, Low
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hospital Italiano de Buenos AiresUniversity, hospital or other
- Study start
- 2 Jan 2020 (actual)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 30 Aug 2022 (estimated)
- First posted
- 18 Sep 2020 (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 is a public health problem. In recent years, oncology has been revolutionized with the advent of new treatments for different tumor models, mainly immunotherapy directed against cell cycle control points. Numerous inhibitory pathways are incorporated into the immune system to maintain tolerance and homeostasis, and these are collectively known as immunological checkpoints.
The main function of immunological checkpoints is to protect tissues from damage when the immune system is responding to pathogens and maintain tolerance to self antigens (ie, prevent autoimmunity). This is mainly achieved by down-regulation of T cell activation or effector functions. There is increasing evidence to show that a primary mechanism by which tumors evade the immune system is through the participation of immunological checkpoints. This has stimulated the development of many novel agents that modulate immunological checkpoints or other costimulatory receptors.
CTLA-4 is the first receptor of the checkpoint that is successfully selected as immunotherapy. Ipilimumab, an anti-CTLA-4 monoclonal antibody, was the first immunological checkpoint inhibitor to receive FDA approval for the treatment of advanced melanoma.
On the other hand, PD-1 is another receptor for the immune control point, and its ligands, the programmed cell death ligand 1 (PD-L1) and PD-L2, also resulted in important therapeutic advances in cancer immunotherapy.
Unlike CTLA-4, PD-1 is widely expressed and can be found in, in addition to T cells, in B cells and natural killer (NK) cells. The main function of PD-1 is to limit the activity of T cells in peripheral tissues during an inflammatory immune response.
The tumors can exploit this control point, expressing the ligand PD-L1 and generating that the cytotoxic T lymphocytes and the NK cells are anergic and incapable of killing. This up-regulation mechanism of PD-L1 is known in tumors such as melanoma, lung and ovary. Several monoclonal antibodies directed to PD-1 have already received approvals for their clinical use as Nivolumab and Pembrolizumab.
Detailed description
The toxic effect of cytostatics (chemotherapy) at the gonadal level is known, but the effect that anti PD-1 immunotherapy can have on the spermogram of oncological patients at the level of the blood-testicular barrier, endocrine axis, among others, is not known. The proinflammatory mechanisms of immunotherapy could incur in damage evidenced as quali-quantitative alterations of the spermogram.
Primary end point:
To evaluate the difference in spermogram (counting, functionality, vitality, mobility) before and after treatment with anti-PD1 immunotherapy first line of oncological treatment of adult patients
Secondary end point:
Evaluate the association adjusted for nutrition, endocrine disorders. Evaluate modifications in the sexual functionality of patients through validated sexuality questionnaires before and during treatment.
In the absence of information, according to the results obtained, cryopreservation prior to the start of treatment could be taken into consideration.
Design: Observational prospective cohort with a single group. With start of follow-up from the oncological diagnosis of patients who are in the process of starting treatment with immunotherapy, checkpoint inhibitors in first line setting. The spermogram samples will be performed: 2 baseline before the start of the drug and +/- 5 days of the start of the treatment, separated by at least 2 weeks. Subsequent samples will be taken 3, 6 and 12 months after the start of treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men on treatment with immunotherapy with check point inhibitors for cancer disease.
Key inclusion criteria (1 listed)
- Diagnosis of cancer with indication for treatment with immunotherapy.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Evaluate sperm count before and after immunotherapyEvaluate sperm count before and after immunotherapy | Behavioural | – |
Primary outcome
To evaluate the difference in the spermogram before and after immunotherapy exposure
Time frame: through study completion, an average of 1 year
To determine differences in sperm count before and after exposure to immunotherapy. Count measured in cells / mm3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2020.
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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. This study is not recruiting at the moment.
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 Sperm Count, Low, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
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 1 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 18 Sep 2020. 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 Argentina. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicolas Minatta, MD (+5491138018573, jose.minatta@hiba.org.ar), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the difference in the spermogram before and after immunotherapy exposure (time frame: through study completion, an average of 1 year). 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 18 Sep 2020.