Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06592846
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-28
Brief Title:
FERtility After Therapy with Intensive Lymphoma in Young Women LNH-03 1B LNH-03 2B LNH-07 3B GAINED Follow-up
Sponsor:
None
Organization:
None
Study Overview
Official Title:
FERtility After Therapy with Intensive Lymphoma in Young Women LNH-03 1B LNH-03 2B LNH-07 3B GAINED Follow-up
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FERTILE
Brief Summary:
The FERTILE study is a retrospective cohort study evaluating fertility after intensive treatment with RCHOP14RCHOP21 or ACVBP in young patients with diffuse large B-cell lymphoma treated in clinical trials conducted by the LYSA group and still alive several years after the end of the trial
Detailed Description:
The FERTILE study is a retrospective cohort study evaluating fertility after intensive treatment with RCHOP14RCHOP21 or ACVBP in young patients 38 years with diffuse large B-cell lymphoma treated in 4 clinical trials conducted by the LYSA group and still alive several years after the end of the trial
Chemotherapy treatments used to treat diffuse large B-cell lymphoma in women of childbearing age may cause loss of fertility
There are few studies dedicated specifically to women treated for non-Hodgkins lymphoma particularly in the context of intensive CHOP-based regimens R-CHOP14R-CHOP21R-ACVBP These studies do not provide any details on the type of treatment and the clinical characteristics of the patients It is in this context that we propose the FERTILE study
This study is based on the collection and reuse of data already available in the LNH03-1B LNH03-2B LNH07-3B and GAINED clinical trials such as the age of the patients the treatments the diagnosis The results of hormonal assessments and fertility tests endovaginal ultrasound will also be consulted in the medical file
In addition a questionnaire concerning fertility will be proposed by the physician-investigator
Chemotherapy treatments used to treat diffuse large B-cell lymphoma in women of childbearing age may cause loss of fertility
There are few studies dedicated specifically to women treated for non-Hodgkins lymphoma particularly in the context of intensive CHOP-based regimens R-CHOP14R-CHOP21R-ACVBP These studies do not provide any details on the type of treatment and the clinical characteristics of the patients It is in this context that we propose the FERTILE study
This study is based on the collection and reuse of data already available in the LNH03-1B LNH03-2B LNH07-3B and GAINED clinical trials such as the age of the patients the treatments the diagnosis The results of hormonal assessments and fertility tests endovaginal ultrasound will also be consulted in the medical file
In addition a questionnaire concerning fertility will be proposed by the physician-investigator
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None