Protocol Details
Natural History, Epidemiology and Pathogenesis of Severe HPV-Related Diseases (Neptune)
This study is currently recruiting participants.
Summary
Number | 21-I-0029 |
Sponsoring Institute | National Institute of Allergy and Infectious Diseases (NIAID) |
Recruitment Detail | Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 3
Max Age: N/A |
Referral Letter Required | Yes |
Population Exclusion(s) | None |
Keywords | Mucosal Disease;
Immunocompromised;
Genetic Defects;
Infection;
Neoplasia;
Natural History |
Recruitment Keyword(s) | None |
Condition(s) | Human Papillomavirus |
Investigational Drug(s) | None |
Investigational Device(s) | None |
Intervention(s) | None |
Supporting Site | National Institute of Allergy and Infectious Diseases |
Background:
Most symptoms of human papillomaviruses (HPV) infection, do not cause serious health problems, but some do. As HPV can cause uncontrolled growth of infected cells, some people can develop benign skin lesions, larger warts, genital lesions, tumors or cysts that do not respond to treatment. Researchers want to learn why.
Objective:
To better understand why some people are more likely than others to get sick from HPV infection, and why medicine or surgery is not always effective.
Eligibility:
People aged 3 years and older who have had multiple outbreaks of HPV-related warts and/or lesions that do not respond to treatment. Healthy relatives are also needed.
Design:
Participants will be screened with a medical history, physical exam, and blood tests.
Participants may have study visits as an outpatient or an inpatient (admitted overnight to the NIH hospital) and be followed over several years by our doctors and researchers at the NIH.
Participants may have a cervical and/or anal Pap test. They may give samples of semen, cervicovaginal secretions, urine, saliva, or stool. Small pieces of skin, the inside of the cheek, and/or the gums may be collected with a punch or scrape biopsy to understand how HPV affect the growth of cells.
Mucus and skin may be collected by rubbing the area with a cotton swab. Collection areas may include the inside the mouth, nostrils, skin, genitals, and/or in or around the anus.
Biopsies may be collected. If participants need to have a biopsy as part of medical care, then we may ask if extra samples can be collected for research. Biopsies we may collect are bone marrow, lymph node, genitals, or in or around the anus.
Participants may have leukapheresis. Blood is taken from a needle placed in one arm. A machine separates out the white blood cells. The rest of the blood is returned through a needle in their other arm.
Samples may be used for genetic tests and/or to make special cells called induced pluripotent stem cells.
Participants may have follow-up visits once a year for 10 years.
Benefits:
We are not testing new HPV treatments in this study and you might not benefit from participating. However, we may learn new information about your condition that we will share with you and your doctor. We may make recommendations for your medical care based on current accepted treatment.
What we learn from you and other participants in this study might help other people. We hope we can use this information to develop new treatments and therapies in the future.
Eligibility
INCLUSION CRITERIA:
Inclusion Criteria for All Participants
1. Aged >=3 years (except for household contacts and sexual partners of participants with HPV-related diseases, who must be aged 18 years and older).
2. Able to provide informed consent or, if younger than 18, be accompanied by a parent(s)/legal guardian(s) who is able to provide informed consent.
3. Willing to allow genetic testing on their collected biological samples.
Additional Inclusion Criteria for Participants with HPV-related Diseases
Has severe, disseminated, recurrent, and treatment-refractory HPV infection, defined as one or more of the following confirmed by medical record review or participant health history:
1. In participants without known primary or acquired immunodeficiency:
a. Multiple skin warts (>=5) recurrent* or refractory to standard-of-care interventions (eg, topical imiquimod, acetylsalicylic acid, cryotherapy, cantharidin, podophyllotoxin, bleomycin, cauterization, cidofovir, fluorouracil).
b. Concomitant skin warts (irrespective to recurrence or treatment response) AND any historical or current clinical and/or histologic or cytologic evidence of mucosal HPV-related diseases (oral, nasal, laryngeal, vaginal, anal, penile, or cervical).
c. Mucosal condyloma or other HPV-related diseases that are recurrent* or refractory to standard-of-care interventions.
d. Historical evidence of mucosal condyloma or any HPV-related diseases occurring irrespective of response to standard-of-care interventions and involving more than one mucosal site.
2. In participants with known primary or acquired immunological defect (including idiopathic CD4 lymphopenia, immunosuppressive treatment, or HIV/AIDS):
a. Any skin OR mucosal HPV-related diseases
3. In any participant:
a. Recurrent invasive skin or mucosal HPV-related squamous cell carcinoma (HPV-SCC).
b. Historical or current histologic evidence of invasive HPV-SCC of any mucosal site in subjects with family history of HPV-SCC in 1 or more family members.
* The lack of complete response to 2 or more interventions is defined as treatment-refractory disease in the protocol, while the reappearance of a skin or mucosal lesion after complete resolution is defined as recurrence.
Additional Inclusion Criteria for Controls
1. Biological relative, household contact, or sexual partner of the index participant (with HPV-related diseases) who meets one of the following criteria:
a. does not have any historical or current clinical and/or histologic or cytologic evidence of skin or mucosal HPV-related diseases, or
b. has historical or current clinical and/or histologic or cytologic evidence of skin or mucosal HPV-related diseases but does not meet the criteria to be enrolled in this study as a participant with HPV-related disease.
EXCLUSION CRITERIA:
Individuals meeting any of the following criteria will be excluded from study participation:
1. Laboratory abnormalities contraindicating research evaluations and procedures in patients without previous history of cytopenias: neutropenia (absolute neutrophil count <500 cells/microL) or thrombocytopenia (platelets <10,000/microL). Medical record review may be used to for determining eligibility if the laboratory tests were collected <= 90 days prior to the screening visit.
2. Inability to reliably keep research appointments and/or adhere to research procedures.
3. Any condition that, in the opinion of the investigator, contraindicates participation in this study.
Additional Exclusion Criteria for Controls
1. Has HPV-related disease that may indicate enrollment as an affected participant rather than as a healthy biological relative, household contact, or sexual partner.
Co-enrollment guidelines: Participants may be co-enrolled in other studies; however, study staff should be notified of co-enrollment.
Citations:
Not Provided
Contacts:
Clinical Trials Number:
NCT05026138Protocol Details
Natural History, Epidemiology and Pathogenesis of Severe HPV-Related Diseases (Neptune)
This study is currently recruiting participants.
Summary
Number | 21-I-0029 |
Sponsoring Institute | National Institute of Allergy and Infectious Diseases (NIAID) |
Recruitment Detail | Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 3
Max Age: N/A |
Referral Letter Required | Yes |
Population Exclusion(s) | None |
Keywords | Mucosal Disease;
Immunocompromised;
Genetic Defects;
Infection;
Neoplasia;
Natural History |
Recruitment Keyword(s) | None |
Condition(s) | Human Papillomavirus |
Investigational Drug(s) | None |
Investigational Device(s) | None |
Intervention(s) | None |
Supporting Site | National Institute of Allergy and Infectious Diseases |
Background:
Most symptoms of human papillomaviruses (HPV) infection, do not cause serious health problems, but some do. As HPV can cause uncontrolled growth of infected cells, some people can develop benign skin lesions, larger warts, genital lesions, tumors or cysts that do not respond to treatment. Researchers want to learn why.
Objective:
To better understand why some people are more likely than others to get sick from HPV infection, and why medicine or surgery is not always effective.
Eligibility:
People aged 3 years and older who have had multiple outbreaks of HPV-related warts and/or lesions that do not respond to treatment. Healthy relatives are also needed.
Design:
Participants will be screened with a medical history, physical exam, and blood tests.
Participants may have study visits as an outpatient or an inpatient (admitted overnight to the NIH hospital) and be followed over several years by our doctors and researchers at the NIH.
Participants may have a cervical and/or anal Pap test. They may give samples of semen, cervicovaginal secretions, urine, saliva, or stool. Small pieces of skin, the inside of the cheek, and/or the gums may be collected with a punch or scrape biopsy to understand how HPV affect the growth of cells.
Mucus and skin may be collected by rubbing the area with a cotton swab. Collection areas may include the inside the mouth, nostrils, skin, genitals, and/or in or around the anus.
Biopsies may be collected. If participants need to have a biopsy as part of medical care, then we may ask if extra samples can be collected for research. Biopsies we may collect are bone marrow, lymph node, genitals, or in or around the anus.
Participants may have leukapheresis. Blood is taken from a needle placed in one arm. A machine separates out the white blood cells. The rest of the blood is returned through a needle in their other arm.
Samples may be used for genetic tests and/or to make special cells called induced pluripotent stem cells.
Participants may have follow-up visits once a year for 10 years.
Benefits:
We are not testing new HPV treatments in this study and you might not benefit from participating. However, we may learn new information about your condition that we will share with you and your doctor. We may make recommendations for your medical care based on current accepted treatment.
What we learn from you and other participants in this study might help other people. We hope we can use this information to develop new treatments and therapies in the future.
Eligibility
INCLUSION CRITERIA:
Inclusion Criteria for All Participants
1. Aged >=3 years (except for household contacts and sexual partners of participants with HPV-related diseases, who must be aged 18 years and older).
2. Able to provide informed consent or, if younger than 18, be accompanied by a parent(s)/legal guardian(s) who is able to provide informed consent.
3. Willing to allow genetic testing on their collected biological samples.
Additional Inclusion Criteria for Participants with HPV-related Diseases
Has severe, disseminated, recurrent, and treatment-refractory HPV infection, defined as one or more of the following confirmed by medical record review or participant health history:
1. In participants without known primary or acquired immunodeficiency:
a. Multiple skin warts (>=5) recurrent* or refractory to standard-of-care interventions (eg, topical imiquimod, acetylsalicylic acid, cryotherapy, cantharidin, podophyllotoxin, bleomycin, cauterization, cidofovir, fluorouracil).
b. Concomitant skin warts (irrespective to recurrence or treatment response) AND any historical or current clinical and/or histologic or cytologic evidence of mucosal HPV-related diseases (oral, nasal, laryngeal, vaginal, anal, penile, or cervical).
c. Mucosal condyloma or other HPV-related diseases that are recurrent* or refractory to standard-of-care interventions.
d. Historical evidence of mucosal condyloma or any HPV-related diseases occurring irrespective of response to standard-of-care interventions and involving more than one mucosal site.
2. In participants with known primary or acquired immunological defect (including idiopathic CD4 lymphopenia, immunosuppressive treatment, or HIV/AIDS):
a. Any skin OR mucosal HPV-related diseases
3. In any participant:
a. Recurrent invasive skin or mucosal HPV-related squamous cell carcinoma (HPV-SCC).
b. Historical or current histologic evidence of invasive HPV-SCC of any mucosal site in subjects with family history of HPV-SCC in 1 or more family members.
* The lack of complete response to 2 or more interventions is defined as treatment-refractory disease in the protocol, while the reappearance of a skin or mucosal lesion after complete resolution is defined as recurrence.
Additional Inclusion Criteria for Controls
1. Biological relative, household contact, or sexual partner of the index participant (with HPV-related diseases) who meets one of the following criteria:
a. does not have any historical or current clinical and/or histologic or cytologic evidence of skin or mucosal HPV-related diseases, or
b. has historical or current clinical and/or histologic or cytologic evidence of skin or mucosal HPV-related diseases but does not meet the criteria to be enrolled in this study as a participant with HPV-related disease.
EXCLUSION CRITERIA:
Individuals meeting any of the following criteria will be excluded from study participation:
1. Laboratory abnormalities contraindicating research evaluations and procedures in patients without previous history of cytopenias: neutropenia (absolute neutrophil count <500 cells/microL) or thrombocytopenia (platelets <10,000/microL). Medical record review may be used to for determining eligibility if the laboratory tests were collected <= 90 days prior to the screening visit.
2. Inability to reliably keep research appointments and/or adhere to research procedures.
3. Any condition that, in the opinion of the investigator, contraindicates participation in this study.
Additional Exclusion Criteria for Controls
1. Has HPV-related disease that may indicate enrollment as an affected participant rather than as a healthy biological relative, household contact, or sexual partner.
Co-enrollment guidelines: Participants may be co-enrolled in other studies; however, study staff should be notified of co-enrollment.
Citations:
Not Provided
Contacts:
Clinical Trials Number:
NCT05026138