Infections

All Conditions

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Immune System Diseases

Communicable Diseases

Papillomavirus Infections

Syphilis

Acquired Immunodeficiency Syndrome

HIV Infections

Immunologic Deficiency Syndromes

Sexually Transmitted Diseases

Chlamydia Infections

Gonorrhea

Virus Diseases

Syndrome

Disease Attributes

Blood-Borne Infections

Sexually Transmitted Diseases, Viral

Lentivirus Infections

Retroviridae Infections

RNA Virus Infections

Slow Virus Diseases

Genital Diseases

Urogenital Diseases

DNA Virus Infections

Tumor Virus Infections

Cohort of transgender people (man to woman and woman to man)

Jade GHOSN, MD PhD

The goal of this observational study is to estimate the prevalence of HPV infections anal and ENT level and according to HIV status in transgender (TG) population. The main question it aims to answer is:

* What is the prevalence of HPV lesions in transgender population (TG);
* What kind of high risk HPV (hrHPV) and low risk HPV (lrHPV) are detected at the genital, anal and ENT level

Context:

The few publications with an individualized transgender (TG) population have been conducted in South America (Peru, Argentina) showing very high anal or ano-genital hrHPV prevalences of around 97% (dos Ramos Farias et al., 2011; Brown et al., 2016). Recently a study conducted in 22 TGs showed a high prevalence of anal dysplastic lesions with low grade lesions detected in 8 individuals and high grade in 3 individuals (Kobayashi et al., 2017). Thus, in the face of this high prevalence of 50% anal dysplasia, the TG population therefore appears to be at risk for developing anal dysplastic lesions and this needs to be explored in another TG population. Furthermore, to our knowledge, no study has evaluated the concomitant prevalence of hrHPV infection at the anogenital and ENT levels in the transgender population. The Infectious and Tropical Diseases Department of Bichat-Claude Bernard Hospital is particularly involved in the follow-up of transgender individuals with a large active file that participates in clinical research projects (Pommier et al., 2019; Bertin et al., 2019; Phung et al., 2018).

Objectives:

Principal objective The primary objective of this study is to determine the prevalence of HPV lesions in transgender population (TG).

Secondary objectives

Secondary objectives include:

1. Estimate the prevalence of HPV infections at the genital, anal and ENT level and according to HIV status;
2. To estimate the prevalence of hrHPV infections at the genital, anal and ENT levels, globally and according to HIV status;
3. To estimate the prevalence of lrHPV infections at the genital, anal and ENT level globally and by HIV status;
4. Describe the types of hrHPV and lrHPV detected at the genital, anal and ENT level;
5. To estimate the prevalence of dysplastic lesions (low grade and high grade) by HIV status;
6. To estimate the prevalence of bacterial Sexually Transmitted Infections (STIs): Neisseria gonorrhoeae, Chlamydia trachomatis and Syphilis, globally and by anatomical site and HIV status.

Methodology This is a national, non-interventional, cross-sectional, monocentric study among TG people (man to woman, and woman to man)

Estimated enrolment 200 participants

Outcomes Primary outcome:

The prevalence of HPV infections among TG people. Prevalence is defined as the percentage of subjects with HPV infection among TG people included, regardless the site where infection was detected.

Secondary outcomes:

1. The prevalence of HPV infections in each anatomical site (genital, anal and ENT) and by HIV status.
2. The prevalence of hrHPV infections in each anatomical site (genital, anal and ENT), globally and according to HIV status.
3. The prevalence of lrHPV infections in each anatomical site (genital, anal and ENT), globally and by HIV status.
4. The types of hrHPV and lrHPV in each anatomical site (genital, anal).
5. The prevalence of dysplastic lesions (low grade and high grade) by HIV status.
6. The prevalence of bacterial STIs: Neisseria gonorrhoeae, Chlamydia trachomatis and Syphilis, globally, by anatomical site and HIV status.

Eligibility Inclusion criteria

* Age ≥ 18 years
* To belong to transgender population : i.e. people who doesn't identify to the gender assigned at birth
* To be affiliated to a social security system or be beneficiary of the Aide Médicale d'Etat (AME)

Non-inclusion criteria

* To have ever been vaccinated against HPV
* Research participation refusal
* People under guardianship or curatorship, or deprived of liberty by administrative or judiciary measure

Statistical methods Individuals' characteristics will be described for all included subjects. Continuous variables will be described using mean, standard deviation, median, interquartiles values, minimal and maximal values. Qualitative variables will be described using numbers and percentages by modality. Prevalences will be described by proportion and their confidence interval will be calculated under binomial law. All statistical tests will be performed using 5% as significance level. Prevalence of high risk HPV infection in each anatomical site and the concordance of HPV types by anatomical site will be determined using Fleiss Kappa test.

HPV Infection, Sexually Transmitted Infections and Anal Dysplasia in the Transgender Population

Prevalence of Genital, Anal and Oral HPV Infection and Sexually Transmitted Infections, and of Anal Dysplasia in the Transgender Population (PrevHPV-TG)

The prevalence of HPV infections is defined as the percentage of subjects with HPV infection among transgender people included, regardless the site of infection.

We will estimate the prevalence of HPV infections in each anatomical site (genital, anal and ENT) and according to HIV status.

We will estimate the prevalence of hrHPV infections in each anatomical site (genital, anal and ENT), globally and according to HIV status.

We will estimate the prevalence of lrHPV infections in each anatomical site (genital, anal and ENT), globally and by HIV status.

We will describe the types of hrHPV and lrHPV detected at the genital, anal and ENT level

We will estimate the prevalence of dysplastic lesions (low grade and high grade) by HIV status.

We will estimate the prevalence of bacterial sexually transmitted infections: Neisseria gonorrhoeae, Chlamydia trachomatis and Syphilis, globally, by anatomical site and HIV status.

ANRS, Emerging Infectious Diseases

Neoplasms

Skin and Connective Tissue Diseases

Breast Neoplasms

Transgender population in France, male to female and female to male.

A flyer with QR code leading to the online questionnaire will be sent to trans associations and healthcare networks for distribution to the target population.

Questionnaire

Virginie GROUTHIER, MD

Clara GUINARD

To date, the transgender population, still poorly characterized, tends to increase. The impact of gender-affirming hormone therapy (GAHT) in this population remains poorly understood, and few data are published on the gynecological repercussions of such therapy. A recent literature review by a French team suggests gynecological follow-up procedures for transgender people.

The hypothesis of this study is that transgender population in France does not have appropriate gynecological care, and the study would like to find out, directly from the people concerned, the current state of gynecological care for transgender people in France. To do this, ths study plan to send out a questionnaire to transgender people (via healthcare networks and also transgender associations) to ask them about their actual gynecological care and their knowledge of recommended gynecological care.

The aim is to set up a descriptive, declarative study based on a questionnaire created specifically for this work.

This project will use a questionnaire for transwomen people and another one for transmen people. Transgender people will be approached via Trans associations and healthcare networks. An online link to the questionnaire will be sent to trans associations and healthcare networks for distribution to the target population thanks to a flyer.

Gynaecological Care for Transgender People in France in 2024.

Percentage of transgender people who know regular gynaecological recommendations in France, thanks to a homemade questionnaire

Overview of organized screening for gynaecological cancers and prostate cancer in the transgender population, thanks to a homemade questionnaire

Overview of knowledge about contraception in the transgender male population,thanks to a homemade questionnaire.

Overview of knowledge about fertility and the impact of hormone treatments in the transgender population, thanks to a homemade questionnaire.

Overview of our knowledge of the gynaecological repercussions of masculinizing hormone treatment in the transgender male population, thanks to a homemade questionnaire.

University Hospital, Bordeaux

Participants will have a clinician-collected cervical screening sample and then collect the following self-samples for research: Vaginal swab, Anal swab, Oral rinse, and Urine sample for the detection of HPV detection.

Participants will collect the following self-samples for research in the clinic: Vaginal swab, Anal swab, Oral rinse, and Urine sample for the detection of HPV detection. Participants will collect the following self-samples for research at home: Vaginal swab, Anal swab, and Oral rinse sample for the detection of HPV detection.

HPV DNA methylation assay to detect HPV positivity, HPV genotype, and HPV methylation.

HPV DNA methylation assay

Alison M Berner

Sophie Ross

Lisa Barbour

James Hand

Kyle Ring

Lucy Campbell

Ellen Adams

Sarah S Jackson, PhD

Alison M Berner, MBBS, PhD

Human papillomavirus (HPV) is a common virus that spreads through skin-to-skin contact. Some HPV types can cause changes in cells that lead to cancer and are known as 'high-risk' HPV (hrHPV). hrHPV is linked to cancers of the cervix (opening of the womb), throat, and anus (exit of the bowel).

It is not known if transgender people (individuals whose gender identity does not align with their sex assigned at birth) are at increased risk of hrHPV or cancers caused by hrHPV compared to cisgender people (individuals whose gender identity does align with their birth sex). There is also little knowledge about HPV in the vagina for transgender women who have surgery to make one.

Transgender men may be at higher risk of cervical cancer than cisgender women because they are less likely to go for screening. This can be because of physical discomfort and emotional distress during screening when a swab is taken directly from the cervix.

The investigators seek to examine how common hrHPV is in transgender people in different parts of the body. In the study, participants will take swabs from the vagina and anus, a urine sample, and use mouthwash. Transgender men will also have an extra swab taken by a clinician as part of routine cervical screening. This is to see if the swab from the vagina is as good as the one from the cervix for finding cells that might lead to cancer. Participants will also take an online survey to measure the acceptability of self-sampling compared to clinician sampling.

This research can inform HPV prevalence and decision-making about HPV screening among transgender people.

Transgender and gender diverse identities.

HPV Self-testing in Transgender Individuals

HPV Methylation Self-testing Pilot in Transgender Individuals

HPV correlation between self-samples at each site (vaginal, anal, oral, and urine) in each arm.

Comparison of the performance of HPV methylation testing from self-collected samples to clinician-collected samples for the detection of cervical precancer in trans men and non-binary adults with a cervix.

Feasibility of self-sampling in clinic as measured by the proportion of completed and returned self-samples.

Acceptability of self-sampling in clinic as indicated by high satisfaction on an online survey

Feasibility of self-sampling at home as measured by the proportion of completed and returned self-samples.

Acceptability of self-sampling at home as indicated by high satisfaction on an online survey

Concordance HPV positivity, overall and by genotype, from self-collected vaginal samples to clinician-collected cervical samples in trans men and nonbinary adults with a cervix.

HPV correlation between self-samples taken at clinic and in-home among trans women and non-binary people.

National Cancer Institute (NCI)

Queen Mary University of London

Virilism

Breast Diseases

Skin Diseases

Persons assigned female or intersex at birth who identify as TGD and are considering gender-affirming chest masculinization surgery.

Gail and IBIS Tools will be utilized to calculate mean lifetime breast cancer risk

Breast Cancer Risk Assessment

Chandler S Cortina

The population of transgender and gender-diverse (TGD) persons in Wisconsin and the U.S. is steadily increasing. As this population grows, the number of individuals seeking gender-affirming therapies, including gender-affirming operations and gender-affirming hormone therapy, is also growing. An example of gender-affirming surgery is chest masculinization surgery, in which most breast tissue is removed in a person assigned female or intersex at birth to allow the chest to appear masculine. Gender-affirming chest masculinization surgery is not generally considered equivalent to an oncologic mastectomy, which aims to removal all breast tissue for future breast cancer reduction or current breast cancer treatment.

The goals of this investigation are to 1) determine the percent of TGD persons considering chest masculinization surgery who have an elevated lifetime risk of breast cancer development and/or a pathogenic genetic mutation; 2) measure the percent who are at risk and choose to undergo risk-reducing mastectomies as part of chest masculinization surgery; and 3) assess and compare self-perceived breast cancer risk with calculated risk.

The results of this study will substantially inform TGD patients and surgeons on the utility of personalized breast cancer risk assessment prior to chest masculinization surgery and the accuracy of self-perceived breast cancer risk in TGD persons.

Persons who identify as transgender, nonbinary, and/or gender-diverse (TGD) who were assigned female and/or intersex at birth.

BC Risk Assessment Before Top Surgery

Assessing Breast Cancer Risk Prior to Gender-Affirming Chest Masculinization Surgery in Transgender and Gender-Diverse Persons

Validated breast cancer risk calculators (IBIS and Gail) will be used to determine lifetime breast cancer risk of participants enrolled into the study. Ranges and 95% CI will be made to estimate the percent of TGD persons at risk.

To determine whether those TGD persons at elevated risk of breast cancer development choose to undergo risk-reducing mastectomies as part of their chest masculinization surgery.

A visual analog scale from 0-100% will be used to compare and assess the self-perceived estimated breast cancer risk with calculated breast cancer risk. 13% is marked as the average cisgender women's risk of breast cancer and participants report their self-perceived risk as single whole integer (ex. 8%, 15%, 25%, etc.) on the scale from 0-100% where 0-12% represents below average risk person and 13-100% represent above average risk.

Medical College of Wisconsin

Assistant Professor of Surgery

Adenocarcinoma

Carcinoma in Situ

Breast Carcinoma In Situ

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

All Drugs and Chemicals

Hormones

Patients who had a breast cancer diagnosis (including those with ductal carcinoma in situ (DCIS)), who were age ≥18 years at the time of diagnosis and identify as a gender and/or sex that is different from their sex assigned at birth (e.g., transgender, nonbinary, genderqueer, etc.) between 1/1/1990 - 7/1/2023.

There is no granular retrospective data on breast cancer in transgender and gender-diverse (TGD) persons from a contemporary and diverse American cohort. The purpose of this investigation is to aggregate data from multiple institutions to describe the risk, diagnosis, management, and outcomes of TGD persons with breast cancer in effort to identify opportunities for future intervention studies to eliminate breast cancer disparities for this population.

Transgender and gender-diverse persons (TGD)

Multi-Institutional Transgender & Gender-Diverse Breast Cancer Study

A Multi-Institutional Retrospect Cohort Study of Breast Cancer Diagnosis and Management in Transgender and Gender-Diverse Individuals

Describe the method of breast cancer diagnosis (self detected vs screen detected vs healthcare provider detected) and compare to the published data from cisgender women by determining means and standard deviation and comparing rates using the Wilcoxon signed-rank test.

Assess breast cancer risk factors (family history, genetics, etc.), including a prior use of gender-affirming hormone therapy and/or gender-affirming surgery on tumor receptor status and stage at diagnosis using t-test and chi-squared test.

Report breast cancer management strategies (type of breast surgery, receipt of radiation, etc.) through descriptive and comparative staststics with a focus on the use of adjuvant endocrine therapy and gender-affirming hormone therapy for patients with hormone-receptor positive disease using t-test and chi-squared test.

Breast cancer local and distant recurrence, overall survival, and disease-free survival using Kaplan-Meier analysis. Cox Proportional Hazards model will be used to estimate the effect of various factors on distant metastasis-free and overall survival.

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Sari Reisner, ScD

The purpose of this study is to assess the acceptability and effectiveness of utilizing vaginal self-swabs for HPV DNA testing as compared to provider-collected cervical swabs for HPV, as well as to investigate the prevalence of other Sexually Transmitted Infections (STIs) among sexually active female-to-male (FTM) transgender adults.

This observational study will examine sexual health in a bio-behavioral cross-sectional mixed-methods design among 150 FTM patients in Boston, Massachusetts, and will determine the acceptability as well as collect epidemiologic data on the comparative performance characteristics of several biological screening modalities in this patient population. Patients and stakeholders are key partners throughout the project and are involved in all phases of study development, implementation, and plans for dissemination.

Eligible participants will participate in a one-time clinical visit. Following written consent, the one-time clinical visit will include: 1) Quantitative assessment; 2) Collection of biological specimens/biomarkers (HPV DNA vaginal self-swab, HPV DNA cervical swab collected by provider, Pap test with cytology, STI testing self- and provider-collected); 3) Qualitative Interview.

A series of national, online focus groups with FTMs, providers, and key stakeholders will occur to gather information on the sexual health needs of FTM individuals outside the Boston area and to ensure that the dissemination of study findings take differing demographic concerns into consideration.

Preventive Sexual Health Screening Among Female-to-Male (FTM) Transgender Adult Patients

Quantitatively assessed the non-inferiority of vaginal self-swab for HPV DNA compared to provider-collected cervical swab for HPV via laboratory confirmed testing in sexually active FTM adults. Compared the concordance of the positive self-swab HPV DNA test results to the positive cervical provider swab HPV DNA test results (reference) using the McNemar's test, a two-sample test for binomial proportions for matched-pair data.

Patient-Centered Outcomes Research Institute

Fenway Community Health

Research Scientist

Descriptive characteristics for the full sample (n=150).

Full Sample

Age, Categorical

Age, Continuous

Trans Masculine/ Male to Female

Sex/Gender, Customized

Race (NIH/OMB)

Yes, Hispanic/Latino

Not Hispanic/Latino

Unknown

Race/Ethnicity, Customized

United States

Region of Enrollment

Diagnosed with Chlamydia - Lifetime

Diagnosed with Gonorrhea - Lifetime

Diagnosed with Syphilis - Lifetime

Diagnosed with Trichomoniasis - Lifetime

Diagnosed with Hepatitis C - Lifetime

Diagnosed with Genital Herpes - Lifetime

Diagnosed with Genital Warts - Lifetime

Don't Know

Prefer Not to Answer

Diagnosed with HPV - Lifetime

Positive

Negative

HIV Status - Lifetime

Abnormal

Normal

Assay could not be tested

Assay not collected

Provider-Collected Cervical Cytology (Current)

Provider-Collected Cervical HPV DNA (Current)

Self-Collected Vaginal HPV DNA (Current)

Enrolled =150, analytic sample =131: 10 participants did not receive the vaginal HPV DNA self-swab and provider cervical swab; 7 received the self-swab, but not the provider; 1 received the provider-swab, but not the self; and 2 did not receive either test. Additionally, 9 of the provider samples could not be assayed due to low cellular content.

Comparing the concordance of the HPV DNA-positive results to the cervical provider swab HPV DNA test results (reference) using the McNemar's test, a two-sample test for binomial proportions for matched-pair data. Null hypothesis: The sensitivities between swab 1 (self-vaginal) and swab 2 (provider-cervical) are equal \[ H0 : p1 = p2 \]

Concordance of HPV DNA detection between self-swab and provider swab assessed via an unweighted Kappa (K) statistic to determine the percentage agreement beyond that expected by chance.

Assessed sensitivity of vaginal self-swab HPV DNA with respect to provider cervical HPV DNA (reference test).

Assessed positive predictive value of vaginal self-swab HPV DNA with respect to provider cervical HPV DNA (reference test).

Assessed negative predictive value of vaginal self-swab HPV DNA with respect to provider cervical HPV DNA (reference test).

Positive vaginal self-swab HPV DNA test

Negative vaginal self-swab HPV DNA test

Positive result determined by reference test: provider cervical HPV DNA Hybridization assay

Participants With Positive Cervical HPV DNA Test Result

Negative result determined by reference test: provider cervical HPV DNA Hybridization assay

Participants With a Negative Cervical HPV DNA Test Result

Analytic sample =131: 10 participants did not receive both the vaginal self-swab HPV DNA test and the provider cervical test (reference); 7 received the self, but not the provider; 1 received the provider, but not the self; 2 did not receive either test. Additionally, 9 of the provider samples could not be assayed due to low cellular content.

Concordance Between Vaginal Self-swab Results and Provider-collected Cervical Swab Results for HPV DNA Among Sexually Active FTM Adults

Overall sample reported as all participants received both the self and the provider swab.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
HPV Infection, Sexually Transmitted Infections and Anal Dysplasia in the Transgender Population	NCT05981807	Human Papilloma... Human Immunodef... Sexually Transm...		18 Years -	ANRS, Emerging Infectious Diseases
Gynaecological Care for Transgender People in France in 2024.	NCT06357130	Transgender Man...	Questionnaire	18 Years -	University Hospital, Bordeaux
Gynaecological Care for Transgender People in France in 2024.	NCT06357130	Transgender Man...	Questionnaire	18 Years -	University Hospital, Bordeaux
HPV Self-testing in Transgender Individuals	NCT05883111	HPV Infection	HPV DNA methyla...	21 Years - 65 Years	Queen Mary University of London
BC Risk Assessment Before Top Surgery	NCT06239766	Breast Cancer Risk Reduction	Breast Cancer R...	18 Years -	Medical College of Wisconsin
HPV Self-testing in Transgender Individuals	NCT05883111	HPV Infection	HPV DNA methyla...	21 Years - 65 Years	Queen Mary University of London
Multi-Institutional Transgender & Gender-Diverse Breast Cancer Study	NCT06234488	Breast Cancer Breast Neoplasm... Breast Adenocar... Breast Cancer S... Breast Cancer S... Breast Cancer I... Breast Cancer i...		18 Years -	Medical College of Wisconsin
Preventive Sexual Health Screening Among Female-to-Male (FTM) Transgender Adult Patients	NCT02401867	Uterine Cervica... Sexually Transm...		21 Years - 64 Years	Fenway Community Health

Spots Global Cancer Trial Database for transgender

Every month we try and update this database with for transgender cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for transgender

Every month we try and update this database with for transgender cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for transgender cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.