Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:11 AM
Ignite Modification Date:
2025-12-25 @ 12:11 AM
NCT ID:
NCT05328258
Eligibility Criteria:
Inclusion Criteria:
* Signed informed consent
* Breast cancer or acute leukemias, lymphomas (Hodgkin and non-Hodgkin) or sarcomas (osteo, soft tissue and Ewing) confirmed by histology and assigned for diseace-specific chemotheraphy
* Confirmed menarche
* ECOG performance status 0-1
* Adequate bone marrow, renal, hepatic and cardiac functions and absence of other uncontrolled medical or psychiatric disorders
Exclusion Criteria:
* Demonstrated premature ovarian failure at time of randomization according to clinical or biochemical data
* Previous or planned bilateral oophorectomy
* Pregnancy or breastfeeding at time of start of chemotherapy
* Other malignancy diagnosed within the last five years
* Uncontrolled hypertension, heart, liver, kidney related or other uncontrolled medical or psychiatric disorders including previous or current diagnosis of anorexia
* Known osteoporosis
* Known low platelet count with increased bleeding risk or refractory thrombocytopenia in subjects with acute leukemias
* Known or suspected allergy against triptorelin
* Direct radiation of the gonads previous or planned (TBI allowed)
* Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
14 Years
Maximum Age:
42 Years
Study:
NCT05328258
Study Brief:
Protocol Section:
NCT05328258