Natural History, Epidemiology and Pathogenesis of Severe HPV-Related Diseases (Neptune)

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 27, 2021

Keywords

ClinConnect Summary

The Neptune trial is studying how severe infections from the human papillomavirus (HPV) affect some people more than others. While many HPV infections are mild, some can lead to serious health issues like persistent warts, lesions, or even tumors that don’t respond to usual treatments. The researchers want to understand why certain individuals experience these severe symptoms and why standard medical interventions sometimes fail.

To participate, you need to be at least 3 years old and have had repeated HPV-related warts or lesions that haven’t improved with treatment. Healthy family members are also welcome to join the study. Participants will go through a series of medical tests, including exams and sample collections, which may involve taking small pieces of skin or other bodily fluids. Although this study is not testing new treatments, the information gathered could lead to better understanding and future therapies for HPV-related conditions. Participants will be followed over several years, and any new findings will be shared with them and their doctors.

Gender

ALL

Eligibility criteria

• * INCLUSION CRITERIA:
• • Inclusion Criteria for All Participants
• • Aged \>=3 years.
• • 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.
• • 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:
• * In participants without known primary or acquired immunodeficiency:
• • Multiple skin warts (\>=5) recurrent\* or refractory to standard-of-care interventions (eg, topical imiquimod, acetylsalicylic acid, cryotherapy, cantharidin, podophyllotoxin, bleomycin, cauterization, cidofovir, fluorouracil).
• • 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).
• • Mucosal HPV-related diseases that are recurrent\* or refractory to standard-of-care interventions and involve more than one mucosal site (eg, anal condyloma and low-grade squamous intraepithelial lesion on Pap smear; or oral and anal condylomas).
• * In participants with known primary or acquired immunological defect (including idiopathic CD4 lymphopenia, immunosuppressive treatment, or HIV/AIDS):
• • --Any skin OR mucosal HPV-related diseases that are recurrent or refractory to standard-of-care intervention.
• * In any participant:
• • Recurrent invasive skin or mucosal HPV-related squamous cell carcinoma (HPV-SCC).
• • 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 Biological Relatives
• -Biological relative of the index participant (with HPV-related diseases) who meets one of the following criteria:
• • does not have any historical or current clinical and/or histologic or cytologic evidence of skin or mucosal HPV-related diseases, or
• • 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:
• • Laboratory abnormalities contraindicating research evaluations and procedures in patients without previous history of cytopenias, : neurtropenia (absolute neutrophil count \<500 cells/microliter) or thrombocytopenia (platelets \<10,000/microliter). Medical record review may be used to for determining eligibility if the laboratory tests were collected \<=90 days prior to the screening visit
• • Inability to reliably keep research appointments and/or adhere to research procedures.
• • Any condition that, in the opinion of the investigator, contraindicates participation in this study.
• • Additional Exclusion Criteria for Healthy Biological Relatives
• • Has HPV-related disease that may indicate enrollment as an affected participant rather than as a healthy biological relative.
• • Co-enrollment guidelines: Participants may be co-enrolled in other studies; however, study staff should be notified of co-enrollment.