Anal CarcinomaGEORGIANCT04713618
Changes in Pelvic Health, Sexual Function, and Quality of Life in Women With Pelvic Cancer Undergoing Radiation Therapy
An observational study of Anal Carcinoma and Cervical Carcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
This study investigates changes in physical measures of pelvic health and patient-reported outcomes of sexual function, intimate relationship, and quality of life over time in women undergoing radiation therapy for pelvic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anal Carcinoma, Cervical Carcinoma, Endometrial Carcinoma
- What is being tested?
- Pelvic Examination and Survey
- Type of treatment
- Surgery or procedure
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2021to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Women with gynecologic and colorectal cancers who are receiving either external beam radiation or brachytherapy from The Ohio State University James Cancer Hospital Radiation Oncology clinic
Who may be able to join
- Any patient with anal, rectal, cervical, endometrial, vaginal, or vulvar cancer receiving external beam radiation alone, brachytherapy alone, or both external beam radiation and brachytherapy
- Concurrent or prior chemotherapy is allowed, including those participating in Ohio State University (OSU)-16166
- Any prior gynecologic surgery is permitted
- Rectal surgery, including lower anterior resection and abdominoperineal resection, is permitted
Who cannot join
- Patients with scleroderma, mixed connective tissue disorder, and lupus will be excluded
- Patients who have received prior pelvic radiation
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
Official title: Longitudinal Changes in Women's Pelvic Health and Sexual Function After Pelvic Radiation
This study investigates changes in physical measures of pelvic health and patient-reported outcomes of sexual function, intimate relationship, and quality of life over time in women undergoing radiation therapy for pelvic cancer. Evaluating vaginal changes prior to and after a course of radiation and collecting patient reported outcomes of sexual function, partner communication, and intimacy may help researchers may help researchers better understand physical changes and symptoms over time.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate changes in objective physical exam findings from baseline to the end of radiation and through two years follow-up for women with pelvic cancer.
II. To examine changes in sexual, relational and quality of life outcomes from baseline to the end of radiation and through one year follow-up for women with pelvic cancer using the patient reported outcome measures.
III. To compare physical exam and patient-reported outcome trajectories over time.
OUTLINE:
Patients undergo standard of care pelvic exam at baseline and 1, 3, 6, 12, and 24 month follow ups. Patients also complete patient reported outcome measures at baseline and 1, 3, 6, 12, 18, and 12 month follow ups.
- Conditions
- Anal Carcinoma, Cervical Carcinoma, Endometrial Carcinoma, Malignant Pelvic Neoplasm, Rectal Carcinoma, Vaginal Carcinoma
- Being tested
- Pelvic Examination, Survey
- Medical subject headings
- Anus Neoplasms, Uterine Cervical Neoplasms, Endometrial Neoplasms, Pelvic Neoplasms, Rectal Neoplasms, Vaginal Neoplasms, Vulvar Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic ExaminationProcedure or surgery
Also called internal examination, Pelvic Exam
Undergo pelvic exam
SurveyOther
Also called Survey Instrument
Complete surveys
| Study group | Role | What they receive |
|---|---|---|
| Supportive Care (pelvic exam, survey) | Patients undergo standard of care pelvic exam at baseline and 1, 3, 6, 12, and 24 month follow ups. Patients also complete patient reported outcome measures at baseline and 1, 3, 6, 12, 18, and 12 month follow ups. Receives: Procedure: Pelvic Examination; Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in physical exam findings
Vaginal Health Assessment (VHA) tool; vaginal length and diameter will be reported as categorical variables (Eaton et al., 2017). Estimates will be <2.5, 2.5, 3.0, 3.5, 4.0 or >4 cm. Vaginal length will be estimated based on manual exam. Estimates will be <4cm, 4-6cm, and >6cm. We will first test bivariate correlations between physical exam outcomes and categorical sociodemographic factors using Fisher's exact test at each time point. The study team will test bivariate correlations between physical exam outcomes and continuous sociodemographic factors using ANOVA at each time point. Next, the study team will employ one-tailed Wilcoxon signed-rank test to assess the effects of radiation by comparing 1-month, 3-month, 6-month, 12-month and 24-month physical exam outcomes to baseline.
Measured: Baseline up to 2 years after radiation therapy (RT)
Change in vulvovaginal symptoms
The Vaginal Assessment Scale (VAS) and Vulvar Assessment Scale (VuAS) are tools to identify vulvovaginal symptoms over the past 4 weeks including vaginal dryness, soreness, irritation, and dyspareunia. Items are scored 0 (none) to 3 (severe) and a composite score is calculated by taking the mean of the items. Will first test bivariate correlations between patient reported outcomes and categorical sociodemographic factors using ANOVA. Will then test bivariate correlations between patient-reported outcomes and continuous sociodemographic factors using Pearson's correlation. Will employ one-tailed paired sample t-test to assess the effects of radiation by comparing patient-reported outcomes at each time point to baseline. Will also report 95% confidence intervals and effect sizes. Will utilize mixed-effects modeling to demonstrate changes in each outcome variable over time adjusting for demographic/clinical characteristics.
Measured: Baseline up to 2 year after RT
Change in sexual function
Female Sexual Functioning Index (FSFI) is a 19 item self -reported instrument measuring six domains of sexual functioning including arousal, orgasm, satisfaction and pain. The maximum score is 36 and a score of ≤ 26.0 indicates sexual dysfunction. Will first test bivariate correlations between patient reported outcomes and categorical sociodemographic factors using ANOVA. Will then test bivariate correlations between patient-reported outcomes and continuous sociodemographic factors using Pearson's correlation. Will employ one-tailed paired sample t-test to assess the effects of radiation by comparing patient-reported outcomes at each time point to baseline. Will also report 95% confidence intervals and effect sizes. Will utilize mixed-effects modeling to demonstrate changes in each outcome variable over time adjusting for demographic/clinical characteristics.
Measured: Baseline up to 2 year after RT
Secondary outcomes (1)
Change in vaginal microbiome
The Lactobacillus to Prevotella ratio (LPR) will be calculated. The vaginal dryness (binary, VAS score <=2 vs >2) will be related to the LPR (continuous) by logistic regression. A significant relationship of LPR with vaginal dryness will be evaluated by Wald test. The LPR is correlated with abundance of macrophages by Spearman correlation. Spearman correlation is used to determine the association between LPR relative abundance and expression of a gene or composition of the immune cells. We will use linear discriminant analysis to explore a linear combination of gene expression, microbe relative abundance and immune cell composition to predict vaginal dryness. The level of inflammation in the tissue will be estimated by aggregating the expression of standard "inflammasome" genes. LPR will be correlated with the aggregated inflammation value by Spearman correlation.
Measured: Baseline up to 2 year after RT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start30 Jan 2021
- Primary completion1 Oct 2023
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal CarcinomaStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe 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
- 72 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Arthur, Ohio State University Comprehensive Cancer Center
- Investigators
- Elizabeth K Arthur, PhD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04713618
- Sponsor's protocol ID
- OSU-19342
- Other IDs
- NCI-2020-04790
- Acronym
- GEORGIA
- Status last verified
- May 2026
- First submitted
- 18 Dec 2020
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Changes in Women's Pelvic Health and Sexual Function After Pelvic Radiation
- ClinicalTrials.gov ID
- NCT04713618
- Acronym / sponsor ID
- GEORGIA / OSU-19342
- Conditions
- Anal Carcinoma, Cervical Carcinoma, Endometrial Carcinoma, Malignant Pelvic Neoplasm, Rectal Carcinoma, Vaginal Carcinoma
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 30 Jan 2021 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates changes in physical measures of pelvic health and patient-reported outcomes of sexual function, intimate relationship, and quality of life over time in women undergoing radiation therapy for pelvic cancer. Evaluating vaginal changes prior to and after a course of radiation and collecting patient reported outcomes of sexual function, partner communication, and intimacy may help researchers may help researchers better understand physical changes and symptoms over time.
Detailed description
PRIMARY OBJECTIVES:
- To evaluate changes in objective physical exam findings from baseline to the end of radiation and through two years follow-up for women with pelvic cancer.
II. To examine changes in sexual, relational and quality of life outcomes from baseline to the end of radiation and through one year follow-up for women with pelvic cancer using the patient reported outcome measures.
III. To compare physical exam and patient-reported outcome trajectories over time.
OUTLINE:
Patients undergo standard of care pelvic exam at baseline and 1, 3, 6, 12, and 24 month follow ups. Patients also complete patient reported outcome measures at baseline and 1, 3, 6, 12, 18, and 12 month follow ups.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive Care (pelvic exam, survey) | – | Procedure: Pelvic Examination, Other: SurveyPatients undergo standard of care pelvic exam at baseline and 1, 3, 6, 12, and 24 month follow ups. Patients also complete patient reported outcome measures at baseline and 1, 3, 6, 12, 18, and 12 month follow ups. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with gynecologic and colorectal cancers who are receiving either external beam radiation or brachytherapy from The Ohio State University James Cancer Hospital Radiation Oncology clinic
Key inclusion criteria (4 listed)
- Any patient with anal, rectal, cervical, endometrial, vaginal, or vulvar cancer receiving external beam radiation alone, brachytherapy alone, or both external beam radiation and brachytherapy
- Concurrent or prior chemotherapy is allowed, including those participating in Ohio State University (OSU)-16166
- Any prior gynecologic surgery is permitted
- Rectal surgery, including lower anterior resection and abdominoperineal resection, is permitted
Key exclusion criteria (2 listed)
- Patients with scleroderma, mixed connective tissue disorder, and lupus will be excluded
- Patients who have received prior pelvic radiation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelvic ExaminationAlso: internal examination, Pelvic ExamUndergo pelvic exam | Procedure or surgery | Supportive Care (pelvic exam, survey) |
| SurveyAlso: Survey InstrumentComplete surveys | Other | Supportive Care (pelvic exam, survey) |
Primary outcome
Change in physical exam findings
Time frame: Baseline up to 2 years after radiation therapy (RT)
Vaginal Health Assessment (VHA) tool; vaginal length and diameter will be reported as categorical variables (Eaton et al., 2017). Estimates will be <2.5, 2.5, 3.0, 3.5, 4.0 or >4 cm. Vaginal length will be estimated based on manual exam. Estimates will be <4cm, 4-6cm, and >6cm. We will first test bivariate correlations between physical exam outcomes and categorical sociodemographic factors using Fisher's exact test at each time point. The study team will test bivariate correlations between physical exam outcomes and continuous sociodemographic factors using ANOVA at each time point. Next, the study team will employ one-tailed Wilcoxon signed-rank test to assess the effects of radiation by comparing 1-month, 3-month, 6-month, 12-month and 24-month physical exam outcomes to baseline.
Change in vulvovaginal symptoms
Time frame: Baseline up to 2 year after RT
The Vaginal Assessment Scale (VAS) and Vulvar Assessment Scale (VuAS) are tools to identify vulvovaginal symptoms over the past 4 weeks including vaginal dryness, soreness, irritation, and dyspareunia. Items are scored 0 (none) to 3 (severe) and a composite score is calculated by taking the mean of the items. Will first test bivariate correlations between patient reported outcomes and categorical sociodemographic factors using ANOVA. Will then test bivariate correlations between patient-reported outcomes and continuous sociodemographic factors using Pearson's correlation. Will employ one-tailed paired sample t-test to assess the effects of radiation by comparing patient-reported outcomes at each time point to baseline. Will also report 95% confidence intervals and effect sizes. Will utilize mixed-effects modeling to demonstrate changes in each outcome variable over time adjusting for demographic/clinical characteristics.
Change in sexual function
Time frame: Baseline up to 2 year after RT
Female Sexual Functioning Index (FSFI) is a 19 item self -reported instrument measuring six domains of sexual functioning including arousal, orgasm, satisfaction and pain. The maximum score is 36 and a score of ≤ 26.0 indicates sexual dysfunction. Will first test bivariate correlations between patient reported outcomes and categorical sociodemographic factors using ANOVA. Will then test bivariate correlations between patient-reported outcomes and continuous sociodemographic factors using Pearson's correlation. Will employ one-tailed paired sample t-test to assess the effects of radiation by comparing patient-reported outcomes at each time point to baseline. Will also report 95% confidence intervals and effect sizes. Will utilize mixed-effects modeling to demonstrate changes in each outcome variable over time adjusting for demographic/clinical characteristics.
1 secondary outcome
Change in vaginal microbiome
Time frame: Baseline up to 2 year after RT
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- The JameslineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth K Arthur, PhD principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anal Carcinoma and Cervical Carcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in physical exam findings (time frame: Baseline up to 2 years after radiation therapy (RT)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.