Ignite Creation Date:
2024-05-06 @ 5:41 PM
Last Modification Date:
2024-10-26 @ 2:33 PM
Study NCT ID:
NCT05394428
Status:
RECRUITING
Last Update Posted:
2024-02-01
First Post:
2022-05-24
Brief Title:
A Multi Center Study of Sexual Toxicities After Radiotherapy
Sponsor:
Icahn School of Medicine at Mount Sinai
Organization:
Icahn School of Medicine at Mount Sinai
Study Overview
Official Title:
Novel Functional Anatomic and Biomarker Indices of Radiation-Induced Female Sexual Toxicities in a Multi-Center Cohort
Status:
RECRUITING
Status Verified Date:
2024-01
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:
STAR
Brief Summary:
The purpose of this research is to understand how radiotherapy and other cancer treatments impact sexual function in female cancer patients and to try to answer a question about why some patients who receive radiotherapy are more likely to have side effects than others The results of this study may improve our understanding of why sexual side effects occur and in turn develop predictive models and biomarkers of sexual side effects and other side effects that may impact sexual function The results of this study may also lead to improvements in the techniques used to deliver radiotherapy or the development of interventions that will prevent or reduce sexual side effects and improve quality of life for female patients with cancer
Detailed Description:
Participants will be asked too
Give consent for past and future access to medical record information At each timepoint the study team will collect data from electronic medical record about demographics health conditions and treatments studies labs imaging and outcomes response to treatment and toxicity
Quality of LifeToxicity Questionnaires Cohort STARQOL The study staff will administer in clinic by phone or by email health and quality of lifetoxicity questionnaires that will ask questions about general well-being and side effects from treatment which will take approximately fifteen minutes each time These questionnaires are required to participate in the study The questionnaires will be completed before treatment after treatment then every six months for two years In addition the study team would like participants to complete a questionnaire every year thereafter and will continue to ask participants to complete the questionnaires as long as they are enrolled unless they decide no longer to participate
Blood Sample Collection Cohort STARQOL a small amount of blood will be drawn from participants arm one specimen up to 45 mL or about 3 tablespoons The blood may be drawn at the same time as routine blood draw for medical care as part of their participation in another research study or solely for this study Biological blood samples will be collected by the treatment team before treatment at the end of treatment 5 weeks after treatment and every 6 months thereafter for two years Participants may be asked if they would like to continue annually after 2 years
Microbiome Sample Collection Cohort STARQOL If participants choose to participate biological microbiome samples a vaginal and stool sample will be collected at home using a home collection kit before treatment after treatment and annually for two yearsParticipants may be asked if they would like to continue annually thereafter
The research on biospecimens may include whole genome sequencing determining the order of DNA building blocks nucleotides in their genetic code and other studies on the DNA such as how DNA is modified or turned in to proteins
Ultrasound Imaging Cohort STARBiomarker
If participants choose to participate ultrasound images will be collected by the treatment team before treatment after treatment and every 6 months for two years thereafter and can be performed at their scheduled office visit for their cancer care rather than requiring an additional visit Additional imaging time may also be added onto their standard MRI scans to allow for additional images to be captured Participants may be asked if they would like to continue annually after 2 years
Give consent for past and future access to medical record information At each timepoint the study team will collect data from electronic medical record about demographics health conditions and treatments studies labs imaging and outcomes response to treatment and toxicity
Quality of LifeToxicity Questionnaires Cohort STARQOL The study staff will administer in clinic by phone or by email health and quality of lifetoxicity questionnaires that will ask questions about general well-being and side effects from treatment which will take approximately fifteen minutes each time These questionnaires are required to participate in the study The questionnaires will be completed before treatment after treatment then every six months for two years In addition the study team would like participants to complete a questionnaire every year thereafter and will continue to ask participants to complete the questionnaires as long as they are enrolled unless they decide no longer to participate
Blood Sample Collection Cohort STARQOL a small amount of blood will be drawn from participants arm one specimen up to 45 mL or about 3 tablespoons The blood may be drawn at the same time as routine blood draw for medical care as part of their participation in another research study or solely for this study Biological blood samples will be collected by the treatment team before treatment at the end of treatment 5 weeks after treatment and every 6 months thereafter for two years Participants may be asked if they would like to continue annually after 2 years
Microbiome Sample Collection Cohort STARQOL If participants choose to participate biological microbiome samples a vaginal and stool sample will be collected at home using a home collection kit before treatment after treatment and annually for two yearsParticipants may be asked if they would like to continue annually thereafter
The research on biospecimens may include whole genome sequencing determining the order of DNA building blocks nucleotides in their genetic code and other studies on the DNA such as how DNA is modified or turned in to proteins
Ultrasound Imaging Cohort STARBiomarker
If participants choose to participate ultrasound images will be collected by the treatment team before treatment after treatment and every 6 months for two years thereafter and can be performed at their scheduled office visit for their cancer care rather than requiring an additional visit Additional imaging time may also be added onto their standard MRI scans to allow for additional images to be captured Participants may be asked if they would like to continue annually after 2 years
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?:
False
Is an FDA AA801 Violation?:
None