Detection of Circulating Therapeutic Monoclonal Antibodies in Biological Samples of Gynecological Cancer Patients.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood samples for the analysis of sildenafil in plasma.
- Who it may be relevant to
- Registry conditions: Gynecological Cancer, Immunotherapy. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Quantification of anti PD-1 mAbs in cancer patients is extremely important to monitor pharmacokinetics and effectiveness of immunotherapy. To detect the ICI mAbs in patients' blood plasma samples, we select three anti PD-1 mAbs (cemiplimab, dostarlimab and pembrolizumab) as prognostic biomarkers which will be quantified using different biochemical/analytical assays.
Interventions
- Procedure Blood samples for the analysis of sildenafil in plasma
To detect the ICI mAbs in patients' blood plasma samples, we select three anti PD-1 mAbs (cemiplimab, dostarlimab and pembrolizumab) as prognostic biomarkers which will be quantified using different biochemical/analytical assays.
Primary outcome measures
- Quantification of anti PD-1. [Time frame: From enrollment to the end of treatment at 4 weeks]
Eligibility criteria
Inclusion criteria
- Patients with a confirmed diagnosis of gynecological malignancy;
- Patients currently undergoing or scheduled to undergo immunotherapy as part of their treatment regimen;
- Age > 18 years;
- Patients who are able and willing to provide written informed consent to participate in the study.
- Availability of biological samples.
Exclusion criteria
- Patients receiving concurrent treatment with other investigational drugs or therapies that may interfere with immunotherapy.
- Presence of significant comorbidities or other medical conditions that, in the opinion of the investigator, would interfere with study participation or interpretation of results (e.g., severe autoimmune diseases, uncontrolled infections);
- Pregnant or breastfeeding women;
- Patients who have received prior monoclonal antibody therapy that could affect the study results;
- Patients who are unable or unwilling to comply with the study procedures and follow-up requirements;
- Brain metastases;
- History of other malignancies within the last 5 years, except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06797479 · ID 7345