Malignant NeoplasmsSTARNCT05394428
A Multi Center Study of Sexual Toxicities After Radiotherapy
An observational study of Malignant Neoplasms, run by Icahn School of Medicine at Mount Sinai at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Malignant Neoplasms
- How many people
- 300 participants
- Where
- 3 sitesUnited States
- Study dates
- 4 Oct 2022to 31 Aug 2027
- How long will I take part?
- 2 Years
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Adult female patients treated with pelvic radiation therapy
Who may be able to join
- Patients with female sexual organs ages 18 and older.
- Patients must meet at least one of the following two criteria:
- have been sexually active in the 36 months prior to initiating cancer treatment.
- have the intent to be sexually active in the 24 months following treatment..
- Patients must be able to provide consent and be willing to participate.
- Patients must have primary anal, rectal, cervical, uterine, vaginal, or vulvar cancer planned to receive pelvic radiotherapy.** Patients must have an Eastern Cooperative Oncology Group performance status <=2.
Who cannot join
- planned for or undergone extensive pelvic surgery (e.g. pelvic exenteration, non-TME techniques, or surgeries otherwise affecting pudendal neurovasculature);
- have clinically or radiologically detectable widespread metastasis;
- have limited life expectancy due to comorbid disease;
- have a personal history of cancer other than non-melanoma skin cancer in the last 5 years;
- have contraindications or strong relative contraindications to radiotherapy at baseline as determined by the treating radiation oncologist (pregnancy, lactation, genetic susceptibility to cancer from ionizing radiotherapy, connective tissue disorders, inflammatory/irritable bowel disease, history of prior pelvic radiotherapy).
- have persistent, infectious gastroenteritis, colitis or gastritis;
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- have persistent or chronic diarrhea of unknown etiology; have recurrent or untreated GI infection (clostridium difficile or H. pylori);
- have current or recurrent vaginal infection;
- have current or recent antibiotic use (within 2 months).
- Patients may be enrolled regardless of previous local or systemic treatments received prior to enrollment in the STAR Study.
- Patients may be enrolled on the STAR Study concurrently with another study or clinical trial.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Emory University
Atlanta, Georgia, 30322
Mylin Torres, MD, BA
- Recruiting
M.D. Anderson Cancer Center
Houston, Texas, 77030
Anuja Jhingran, MD
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Deborah C Marshall, MD
Julia Brody-Barre, 201-500-55225, julia.brody-barre@mountsinai.org
About this study
Official title: Novel Functional Anatomic and Biomarker Indices of Radiation-Induced Female Sexual Toxicities in a Multi-Center Cohort
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.
Read the 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 Life/Toxicity Questionnaires (Cohort: STAR*QOL): The study staff will administer (in clinic, by phone, or by email) health and quality of life/toxicity 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: STAR*QOL): 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: STAR*QOL): 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 years.Participants 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: STAR*Biomarker):
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.
- Conditions
- Malignant Neoplasms
- Being tested
- No intervention
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Patients with female sexual organs treated with pelvic radiotherapy | Patients with female sexual organs treated with pelvic radiotherapy. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish Sexual Quality of Life Cohort
Establish a cohort of patients with female sexual organs receiving radiotherapy
Measured: 2 years
Secondary outcomes (4)
Describe sexual quality of life
Describe sexual quality of life for patients with female sexual organs receiving radiotherapy
Measured: 2 years
Describe dosimetric predictors of sexual outcomes
Describe the dosimetric predictors of sexual outcomes for patients with female sexual organs receiving radiotherapy
Measured: 2 years
Describe imaging predictors of sexual outcomes
Describe the imaging predictors of sexual outcomes for patients with female sexual organs receiving radiotherapy
Measured: 2 years
Describe microbiome predictors of sexual outcomes
Describe the microbiome predictors of sexual outcomes for patients with female sexual organs receiving radiotherapy
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2022
- Study start4 Oct 2022
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant NeoplasmsStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Emory University, M.D. Anderson Cancer Center
- Responsible party
- Principal investigator, Deborah Marshall, Icahn School of Medicine at Mount Sinai
- Investigators
- Deborah C Marshall, MD MAS, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05394428
- Sponsor's protocol ID
- GCO 20-2369
- Acronym
- STAR
- Status last verified
- Jun 2026
- First submitted
- 24 May 2022
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported including individual-level quality-controlled individual microbiome 16s rRNA genomic sequencing and clinical correlative information. Data repositories will include an institutional controlled-access database available to the investigators and any other qualified investigator who has sought the approval of the investigators to pursue additional studies, in addition to depositing the study data in the unrestricted-access Sequence Read Archive database, a NIH-designated Data Repository supported by the NCBI.