Anal Dysplasia

Researchers are evaluating the safety and effects of Papillex4, a dietary supplement, on the regression of abnormal cervical cells caused by HPV in women diagnosed with cervical intraepithelial neoplasia (CIN) grades 1 or 2. The main goal is to see if Papillex4 leads to a greater improvement in cervical cell abnormalities compared to a placebo by day 180. Participants will take either Papillex4 or a placebo twice daily for 180 days. Papillex4 contains vitamins, minerals, plant extracts, and other natural substances. Both groups will follow the same dosing schedule with two capsules taken with the first and last meals each day. The study design is randomized and quadruple-blinded, meaning neither participants nor researchers know who receives Papillex4 or placebo. During the study, participants will undergo clinical visits, complete questionnaires, and have cervical cell assessments including PAP smears and HPV tests. Some may have colonoscopy if applicable. Researchers will measure changes in cervical cell abnormalities, HPV clearance, immune markers, micronutrient status, symptom scores, quality of life, and monitor safety events over 180 to 360 days. Participants are expected to maintain their usual lifestyle habits and complete all study activities and visits.

This research aims to study the immune response to the nonavalent HPV (9vHPV) vaccine in women living with HIV (WLWH), a group particularly vulnerable to HPV and cervical cancer. There is limited data on reduced-dose schedules of the 9vHPV vaccine in this population, which is important as the previously used quadrivalent HPV vaccine has been discontinued. The study seeks to inform global strategies for cervical cancer elimination by evaluating different dosing schedules in WLWH aged 18 to 45 years. Participants will be randomly assigned to one of two groups: one group will receive three doses of the 9vHPV vaccine following the routine schedule at 0, 2, and 6 months, while the other group will receive two doses at 0 and 6 months, with a third dose at month 12. This design follows current recommendations and allows comparison of immune responses between the routine and extended dosing schedules. During the two-year follow-up, participants will undergo regular assessments to measure immune responses, specifically anti-HPV16/18 antibody levels at months 7 and 24. Researchers will also evaluate vaccine safety, effectiveness, and attitudes toward self-collected HPV samples. Surveys will assess vaccine acceptability and comfort. The study includes monitoring for adverse events and aims to provide data to improve HPV vaccination programs for WLWH globally.

Researchers are evaluating whether using lower doses of radiation can reduce side effects when combined with standard chemotherapy in people with HPV-positive throat cancer. This Phase 2 study focuses on patients with hypoxia negative human papilloma virus (HPV) associated oropharyngeal carcinoma, aiming to improve treatment tolerability while maintaining effectiveness. Chemotherapy drugs involved include cisplatin, carboplatin, 5-fluorouracil (5-FU), paclitaxel, and Abraxane (albumin-bound paclitaxel). Participants are assigned to one of four cohorts based on their specific clinical characteristics. Treatments include radiation over three weeks with a total dose of 30 Gy in 2 Gy fractions, combined with chemotherapy regimens varying by cohort. For example, Cohort B receives carboplatin and paclitaxel starting the same week as radiation; Cohort C includes induction chemotherapy before radiation; and Cohort D focuses on early-stage cases. The study also uses 18F-FMISO PET/CT scans for diagnostic imaging before and during treatment to guide therapy. During the study, participants undergo regular assessments including imaging scans, blood tests to evaluate blood counts and organ function, and clinical evaluations to monitor disease status and side effects. Researchers will measure the number of participants experiencing locoregional cancer recurrence over 2 years. Participants must provide informed consent and comply with study procedures, including MRI scans unless contraindicated. The total participation duration varies depending on treatment and follow-up schedules.

Researchers are evaluating whether monitoring HPV circulating tumor DNA (ctDNA) levels can effectively detect the risk of cancer returning in people with HPV-associated oropharynx cancer (HPV-OPC) who have recently undergone or are scheduled for surgery. The study aims to determine if this monitoring can guide decisions about radiation therapy and chemotherapy, potentially allowing for delayed or reduced treatment. This is a Phase II trial sponsored by Memorial Sloan Kettering Cancer Center. Participants are divided into two groups. In Arm A, those with rising HPV ctDNA levels after surgery may have radiation therapy delayed until ctDNA becomes detectable, with radiation doses of 50-60 Gy planned. In Arm B, patients typically needing 6 to 6.5 weeks of chemoradiation may receive a shorter, 3-week course of radiation with concurrent chemotherapy. Both arms involve detailed imaging with FDG PET/CT scans for treatment planning and to check for cancer spread. Throughout the study, participants will undergo blood tests to measure HPV ctDNA, imaging scans, and complete questionnaires assessing quality of life and financial impact. Researchers will track progression-free survival over two years, along with detailed monitoring of treatment effects. Treatment is personalized based on ctDNA results and pathology findings, with ongoing assessments for safety and effectiveness during follow-up visits.

Researchers are investigating the tumor biology related to treatment response in patients with anal cancer. They aim to understand the tumor microenvironment, the location and interactions between tumor and immune cells, and the gene and protein expression in tumor and surrounding tissues. This study focuses on adult patients treated or diagnosed at Sahlgrenska University Hospital. Participants who are newly diagnosed or have a suspected recurrence will be invited to provide biopsies and blood samples during diagnostic exams performed under anesthesia. Additional biopsies may be collected during follow-up exams, surgery, or further anesthesia examinations after treatment. If biopsies cannot be taken before treatment, blood samples will still be collected. During the study, patients will undergo biopsies and blood sample collection at various time points including diagnosis, recurrence, and follow-up. Researchers will monitor the tumor microenvironment and circulating tumor DNA from 2024 to 2029. The study will gather detailed biological information to help predict treatment response and outcomes in anal cancer. Participation involves regular medical assessments and sample collections over several years.

Researchers are evaluating the tissue-agnostic effectiveness of the anti-PD1 antibody nivolumab in patients with advanced or metastatic rare tumors that express PD-L1 with a combined positive score of 10 or higher. This phase II basket trial includes patients whose cancers have progressed despite standard treatments. Rare tumors, defined by low incidence rates, collectively represent a significant portion of cancers with generally poor prognosis and limited clinical trial representation. Participants receive intravenous nivolumab at a dose of 480 mg every 4 weeks, continuing until disease progression, limiting toxicity, or for up to 12 months if responses are stable or improving. After treatment ends or discontinuation, patients are followed by phone every 60 days until death. This innovative approach targets the molecular characteristic PD-L1 regardless of tumor origin, aiming to provide new therapeutic options across many rare cancer types. During the study, researchers assess tumor response using RECIST v1.1 criteria and monitor biomarkers including PD-L1 expression, circulating tumor DNA, and microvesicles to understand treatment effects. Patients undergo regular evaluations to measure objective response and progression-free survival. Safety is closely monitored throughout the treatment and follow-up periods. The study is conducted across multiple centers to overcome challenges in rare cancer research and is expected to last about four years.

Researchers are evaluating the performance of the BD Onclarity HPV Assay on anal specimens to improve screening for anal cancer and precancerous lesions. Anal cancer is rare in the general population but more common in high-risk groups such as immunosuppressed individuals, men who have sex with men, and women with HPV-related genital tract diseases. Persistent infection with high-risk HPV types can lead to progression from precancerous lesions to invasive anal cancer. Currently, no HPV test is validated for anal samples, and screening methods vary without a uniform approach. The BD Onclarity HPV Assay is a real-time PCR test that detects DNA from 14 high-risk HPV types and provides detailed genotyping for six individual types and three groups of types. The test uses DNA extracted from anal samples and aims to enable less invasive anal cancer screening. The study includes subjects with both low-grade and high-grade anal intraepithelial neoplasia, invasive anal cancer, and individuals at increased risk due to immune status or medical history. Participants undergo testing with this assay to assess its accuracy. Participants may be patients with confirmed precancerous or cancerous anal lesions or those at high risk, including people with HIV, organ transplant recipients, men who have sex with men, women with prior genital HPV disease, and those with Crohn's disease affecting the anal area. The study tracks the test's sensitivity and specificity over four years. Consent is required, and participants are monitored to help determine the test's usefulness in anal cancer screening programs.

Anal cancer is a rare but increasing disease, with about 200 new patients yearly in Sweden. This research aims to understand the quality of life and functional outcomes in patients diagnosed with anal cancer. The study focuses on identifying early side effects from treatment and long-term health issues after diagnosis and treatment. The study involves patients diagnosed with anal cancer who will be invited to participate after identification at a national tumor board. Participants will complete questionnaires about their quality of life, urinary, bowel, and sexual function at multiple time points: at diagnosis, then 3, 12, 36, 60, and 120 months after diagnosis. Participants will be followed and asked to fill out these questionnaires over several years to monitor changes and outcomes related to their condition and treatment. Researchers will measure quality of life and bodily functions at 3 months, 12 months, and 3 years after diagnosis to understand treatment toxicity and long-term effects. The study may continue up to 2035, providing long-term data on patient outcomes.

Researchers are evaluating artesunate ointment in a phase II, double-blind, placebo-controlled, randomized study for adults with biopsy-confirmed anal high-grade squamous intraepithelial lesions (anal HSIL) who are HIV-negative. The study aims to assess the complete and partial tissue response to the ointment, as well as evaluate viral clearance and safety. Anal HSIL is related to HPV infection and requires effective treatment options to prevent progression. Participants are randomly assigned in a 2:1 ratio to receive either artesunate ointment or placebo. Both groups apply four 5-day cycles of ointment at weeks 0, 2, 4, and 6. Follow-up includes anoscopy or high-resolution anoscopy (HRA) visits at weeks 8, 18, 30, and 42. Those showing partial or complete response at week 18 continue follow-up with HRA at week 30. Non-responders at week 18 receive standard ablation treatment. During the study, participants undergo regular anoscopy or HRA exams to monitor lesion response and viral clearance. Safety is closely monitored throughout. Participants with persistent anal HSIL at weeks 30 or 42 follow standard care procedures. The primary outcome is the histopathologic response by week 18, with secondary outcomes including HPV clearance and response persistence through week 42. The total study period extends up to 42 weeks, with ongoing safety evaluation.

Researchers are conducting a study to understand the knowledge and opinions about anal cancer screening among men who have sex with men (MSM). The study aims to gather information on their experiences receiving care that follows guidelines to reduce the risk of anal cancer. This research uses a large-scale survey shared through social media platforms. Participants will complete a one-time electronic survey accessible via popular Meta-based social media platforms like Facebook and Instagram. The study does not involve any treatment or medication but focuses on collecting observational data through this survey. Men who take part will be asked about their awareness of anal cancer risk and the strategies to lower that risk. The study will measure these outcomes over a period of two months. Participation involves completing the survey, and safety monitoring or follow-up is not required as this is an observational study. The total time commitment depends on the survey completion.