Ignite Creation Date:
2024-05-06 @ 5:49 PM
Last Modification Date:
2024-10-26 @ 2:36 PM
Study NCT ID:
NCT05440617
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2022-06-30
Brief Title:
Biorepository in Participants Who Undergo OTC for Gonadotoxic Therapy
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Biorepository in Participants Who Undergo OTC for Gonadotoxic Therapy
Status:
RECRUITING
Status Verified Date:
2024-10-10
Last Known Status:
None
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:
Background
Medical advances have improved survival rates for many cancers and other illnesses This means that more people are coping with the long-term effects of these treatments Some treatments can cause female infertility Ovarian tissue cryopreservation OTC may help Before undergoing a treatment that may damage their fertility patients may opt to freeze a sample of ovarian tissue The tissue contains immature egg cells When thawed the tissue can be reimplanted This procedure can help women become pregnant
Objective
This natural history study will create a databank of ovarian tissue The NIH will provide OTC as a clinical service The NIH will also request a portion of the tissue to use for research
Eligibility
Females aged 4 to 35 who opt to have OTC before receiving cancer treatment
Design
Participants will be screened Their existing medical records will be reviewed
They will be asked if they want to donate a portion of their ovarian tissue for research No more than 20 of the tissue collected will be taken for research Some other tissues that would otherwise be discarded will also be kept
Medical data from each participant may also be collected and stored in the database This data may include results of routine blood tests imaging tests and other information The data will be coded for privacy
Participants will answer a questionnaire They will be asked about their fertility treatment and general health The survey takes about 30 minutes
They will repeat the questionnaire once a year for 30 years
Medical advances have improved survival rates for many cancers and other illnesses This means that more people are coping with the long-term effects of these treatments Some treatments can cause female infertility Ovarian tissue cryopreservation OTC may help Before undergoing a treatment that may damage their fertility patients may opt to freeze a sample of ovarian tissue The tissue contains immature egg cells When thawed the tissue can be reimplanted This procedure can help women become pregnant
Objective
This natural history study will create a databank of ovarian tissue The NIH will provide OTC as a clinical service The NIH will also request a portion of the tissue to use for research
Eligibility
Females aged 4 to 35 who opt to have OTC before receiving cancer treatment
Design
Participants will be screened Their existing medical records will be reviewed
They will be asked if they want to donate a portion of their ovarian tissue for research No more than 20 of the tissue collected will be taken for research Some other tissues that would otherwise be discarded will also be kept
Medical data from each participant may also be collected and stored in the database This data may include results of routine blood tests imaging tests and other information The data will be coded for privacy
Participants will answer a questionnaire They will be asked about their fertility treatment and general health The survey takes about 30 minutes
They will repeat the questionnaire once a year for 30 years
Detailed Description:
Study Description
We will provide ovarian tissue cryopreservation OTC as a clinical service at NIH and collect a portion of the tissue for research regarding normal histology and function of the human ovary In addition de-identified data will be entered in a national database which will allow future research regarding short term and long term complications Including impact of therapy on remaining ovarian function as well as long term outcomes including reproductive health outcomes including rate of tissue reimplantation and pregnancies
Objectives
Primary objective is to create a databank of human ovarian tissue to elucidate histology and function in human ovaries
Secondary objective will be to populate a national database of individuals who have undergone OTC in order to elucidate short and long term outcomes including complications and reproductive health parameters
We will provide ovarian tissue cryopreservation OTC as a clinical service at NIH and collect a portion of the tissue for research regarding normal histology and function of the human ovary In addition de-identified data will be entered in a national database which will allow future research regarding short term and long term complications Including impact of therapy on remaining ovarian function as well as long term outcomes including reproductive health outcomes including rate of tissue reimplantation and pregnancies
Objectives
Primary objective is to create a databank of human ovarian tissue to elucidate histology and function in human ovaries
Secondary objective will be to populate a national database of individuals who have undergone OTC in order to elucidate short and long term outcomes including complications and reproductive health parameters
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 000715-CH | None | None | None |