Ignite Creation Date:
2024-05-06 @ 3:11 PM
Last Modification Date:
2024-10-26 @ 1:45 PM
Study NCT ID:
NCT04554030
Status:
UNKNOWN
Last Update Posted:
2020-09-18
First Post:
2020-01-02
Brief Title:
Impact of Immunotherapy on the Sperm Count of Patients With Cancer
Sponsor:
Hospital Italiano de Buenos Aires
Organization:
Hospital Italiano de Buenos Aires
Study Overview
Official Title:
Impact of Immunotherapy in the Spermogram
Status:
UNKNOWN
Status Verified Date:
2020-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None