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Human Papilloma Virus (HPV) Circulating Tumor DNA (ctDNA) in Cervical Cancer
Rochester, MN
The purpose of this study is to answer whether plasma circulating tumor DNA (ctDNA) obtained by serial analysis before, during, and following surgery, radiotherapy, chemotherapy, and/or immunotherapy for cervical cancer will allow for risk stratification, individualized treatment decision making, monitoring of treatment response, and early detection of residual or recurrent disease in patients presenting with human papillomavirus (HPV) mediated cervical cancer.
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Studying Biomarkers in Diagnosing Cervical Lesions in Patients with Abnormal Cervical Cells
Rochester, MN
This clinical trial is studying biomarkers in diagnosing cervical lesions in patients with abnormal cervical cells. Studying biomarkers in abnormal cervical cells may improve the ability to find cervical lesions and plan effective treatment.
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A Study of Combination Radiation Therapy and Cisplatin with or without Triapine for Treating Patients with Newly Diagnosed Stage IB2, II, or IIIB-IVA Cervical Cancer or Stage II-IVA Vaginal Cancer
Jacksonville, FL; Rochester, MN
The purpose of this study is to see how well radiation therapy and cisplatin with triapine work in combination compared to the standard radiation therapy and cisplatin alone to treat patients with newly diagnosed stage IB2, II, or IIIB-IVA cervical cancer or stage II-IVA vaginal cancer. Radiation therapy uses high energy protons to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing or by stopping them from spreading. Triapine may stop the growth of tumor cells ...
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Leveraging Methylated DNA Markers (MDMs) in the Detection of Endometrial Cancer and Cervical Cancer: a Phase II Clinical Study
Rochester, MN; Jacksonville, FL; Scottsdale/Phoenix, AZ
The purpose of this study is to develop a pan-gynecologic cancer detection test using gynecologic (unique endometrial, cervical, and ovarian cancer) cancer-specific methylated DNA markers and high-risk human papilloma virus (HR-HPV) detected in vaginal fluid and/or plasma.
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Patient Self-sampling of HPV to Screen for Cervical Cancer
Rochester, MN
The purpose of this study is to validate a patient self-sampling vaginal collection kit and laboratory testing for the detection of HPV (human papillomavirus) infection. Its secondary aim is to assess the patient perspective on acceptability and feasibility of a self-sampling approach to cervical cancer screening through a survey of study enrollees. The third aim will assess the stability testing component to analyze concordance of multiple self-collected Evalyn brush HPV results within the same study subject.
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A Study to Evaluate the Awareness and Acceptability of Primary HPV Testing and Self Collection for Cervical Cancer in Patients and Primary Care Physicians
Rochester, MN
The purposes of this study are to assess awareness and acceptability of HPV testing for cervical cancer screening and patient self-collection of vaginal swabs among women aged 30 to 65 years old, to assess awareness and acceptability of HPV testing for cervical cancer screening and patient self-collection of vaginal swabs among primary care clinicians, and to identify insights from regional and national thought leaders in the fields of primary care and cervical cancer screening on strategies to improve uptake of primary HPV screening and opinions on patient self-collection by conducting key informant interviews.
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Lymphedema After Surgery in Patients With Endometrial Cancer, Cervical Cancer, or Vulvar Cancer
Scottsdale/Phoenix, AZ; Rochester, MN
This clinical trial studies lymphedema after surgery in patients with endometrial cancer, cervical cancer, or vulvar cancer. Collecting information over time about how often lymphedema occurs in patients undergoing surgery and lymphadenectomy for endometrial cancer, cervical cancer, and vulvar cancer may help doctors learn more about the disease and plan the best treatment.
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Cancer Prevention: Stories for Change in Hispanic Community
Rochester, MN
This study is a process evaluation of a digital storytelling (DST) intervention. Because the DST intervention has not yet been developed, it is appropriate to use qualitative methods to assess the process.
This study will recruit gifted storytellers for a digital storytelling intervention on breast, cervical, and colorectal cancer. A digital storytelling intervention will be developed to improve breast, cervical, and colorectal cancer screening rates among Hispanic, Spanish speaking individuals. Additionally, to conduct a qualitative assessment of the digital storytelling workshop.
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Comprehensive Patient Questionnaires in Predicting Complications in Older Patients With Gynecologic Cancer Undergoing Surgery
Rochester, MN
This research trial studies comprehensive patient questionnaires in predicting complications in older patients with gynecologic cancer undergoing surgery. Comprehensive patient questionnaires completed before surgery may help identify complications, such as the need for assistance in taking medications, decreased mobility, decreased social activity, and falls, and may improve outcomes for older patients with gynecologic cancer.
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Phase 1-2 Study of ADXS11-001 or MEDI4736 Alone or Combo In Cervical or HPV+ Head & Neck Cancer
Jacksonville, FL
Part A: (ADXS11-001 + MEDI4736 Combination Therapy) will determine the safety and tolerability of the combination and to identify a RP2D.
Part B: Phase 2 design which will randomize subjects 1:1 to either MEDI4736 alone or MEDI4736+ADXS11-001 in subjects who have failed at least 1 prior systemic treatment for their recurrent/persistent or metastatic cervical cancer.
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Establishment of Preclinical Models from Patients with Gynecological Malignancies
Rochester, MN; Scottsdale/Phoenix, AZ
Effective treatments for recurrent gynecological cancer are lacking, and there is a need for novel therapeutic options. One of the barriers to improving outcomes in this subgroup of patients is the paucity of tumor models that can mimic patient characteristics to study novel therapies. Patient-derived xenograft (PDX) models are considerate the most representative pre-clinical model of human cancer, recapitulating the key characteristics of the original patient tumor. Other preclincal models to test drug effcicacy includes ex vivo 3D culture and 2D culture systems. In this study, we make and test preclinical models of gynecological cancers (ovarian, fallopian tube, peritoneal, uterine, ...
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IRB#21-009968: Assessing the Sexual Health and Well-Being of Female Survivors of Pelvic Malignancies after Radiotherapy
Rochester, MN
The purpose of this study is to quantify the extent of sexual dysfunction in our patients to explore if there is a need for a prospective intervention, with the ultimate goal of improving the quality of life of our patients, with respect to sexual function.
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Serum Bovine Immunoglobulin Protein Isolate in Improving Quality of Life and Post-Operative Recovery in Patients With Gynecological Cancer After Undergoing Surgery
Rochester, MN
This randomized pilot phase II trial studies how well serum bovine immunoglobulin protein isolate works in improving quality of life and post-operative recovery in patients with gynecological cancer after undergoing surgery. Serum bovine immunoglobulin supplementation may improve the quality of life of patients with gynecological cancer.
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A Study to Determine the Best Individualized Cancer Therapy Using Circulating Tumor DNA (ctDNA) in Patients with GI, CNS, and Thoracic Cancers.
Jacksonville, FL
This study proposes to develop and maintain a biorepository of blood samples collected from patients receiving definitive chemoradiotherapy for locally advanced rectal cancer, locally advanced pancreatic cancer, non-small cell lung cancer, or cervical cancer. The ultimate goal of this biorepository will be to provide the resource to initiate an exploration of ctDNA as a potential liquid biopsy for GI and Thoracic malignancy detection and surveillance.
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A Study of PY314 in Subjects With Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
A Phase 1a/1b Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PY314 as a Single Agent and In Combination with Pembrolizumab in Subjects with Advanced Solid Tumors
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Study of TBio-6517, Given Intratumorally, Alone or in Combination With Pembrolizumab, in Solid Tumors
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
The purpose of this study is to determine the recommended Phase 2 dose (RP2D) of TBio-6517 when administered by direct injection into tumor(s) alone and when combined with pembrolizumab in patients with solid tumors (RIVAL-01).
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Nab-Paclitaxel and Bevacizumab in Treating Patients With Unresectable Stage IV Melanoma or Gynecological Cancers
Rochester, MN; Scottsdale/Phoenix, AZ; Jacksonville, FL
This phase I trial studies the side effects and best dose of paclitaxel albumin-stabilized nanoparticle formulation and bevacizumab in treating patients with stage IV melanoma, gynecological cancers, or other malignancies that cannot be removed by surgery. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing ...
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A Trial to Evaluate the Safety of GEN1046 in Patients with Malignant Solid Tumors
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
The purpose of this trial is to evaluate the safety of GEN1046 in patients with malignant solid tumors.
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An Investigational Immuno-therapy Study to Assess the Safety, Tolerability and Effectiveness of Anti-LAG-3 With and Without Anti-PD-1 in the Treatment of Solid Tumors
Rochester, MN
The purpose of the study is to assess the safety, tolerability and effectiveness of experimental medication BMS-986016 administered alone and in combination with nivolumab in patients with solid tumors that have spread and/or cannot be removed by surgery. The following tumor types are included in this study: Non-Small Cell Lung Cancer (NSCLC), gastric cancer, hepatocellular carcinoma, renal cell carcinoma, bladder cancer, squamous cell carcinoma of the head and neck, and melanoma, that have NOT previously been treated with immunotherapy. NSCLC and melanoma that HAVE previously been treated with immunotherapy.
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Immune Response to Antigens
Jacksonville, FL
The purpose of this study is to sequence patient germline and tumor samples, and nominate top neoantigen candidates using an in-house developed bioinformatics pipeline, and to validate the neoantigen candidates by laboratory assays using patient peripheral blood immune cells or serum.
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A Study of HFB200301 in Adult Patients With Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to test the safety and tolerability of HFB200301 in patients with advanced cancers. There are two parts in this study. During the escalation part, groups of participants will receive increasing doses until a safe and tolerable dose of HFB200301 is determined. During the expansion part, participants will take the dose of study drug that was determined from the escalation part of the study and will be assigned to a group based on the type of cancer the participants have.
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Gemini Study to Evaluate the Integration of Cancer Genetic Testing into a Cancer Clinical Practice at Mayo Clinic at Arizona
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to determine the prevalence of genetic mutations in cancer patients from various ethnic populations seeking care at Mayo Clinic cancer clinics.
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cfDNA Assay Prospective Observational Validation for Early Cancer Detection and Minimal Residual Disease (CAMPERR)
Rochester, MN
The purpose of this multicenter prospective observational case-control study is to train and validate Adela’s cfMeDIP-seq based methylome profiling platform to detect and differentiate multiple cancer subtypes. In addition, this study includes longitudinal follow-up for a subset of participants to train and validate the methylome profiling platform to detect minimal residual disease and recurrence.
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An Expansion Study to Evaluate Dose Escalation, Safety and Tolerability of SAR444881 in Patients with Advanced Solid Tumors
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate the safety, tolerability, and preliminary anti-tumor activity of SAR444881 alone and in combination with pembrolizumab or with cetuximab. The study will enroll advanced cancer patients with unresectable or metastatic disease who are refractory to or are not candidates for standard approved therapy and will be comprised of two parts - an initial "3 + 3" dose escalation phase (Part 1) with Sub-Parts 1A (monotherapy SAR444881), 1B (SAR444881 in combination with pembrolizumab) and 1C (SAR444881 in combination with cetuximab) followed by a dose optimization/expansion phase (Part 2), including Sub-Part 2A (Dose Optimization) with Cohorts A1 (SAR444881 in ...
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Understanding the Challenges, Behavioral Patterns, and Preferences Towards Participation in Clinical Trials in Minority Patient Populations
Jacksonville, FL; Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate the challenges, behavioral patterns, and preferences of minority patient participation in clinical trials. Also, to develop and validate a personalized clinical trial educational platform to boost participation among underserved cancer patients.
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The Circulating Cell-free Genome Atlas Study
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
GRAIL is using deep sequencing of circulating cell-free nucleic acids (cfNAs) to develop assays to detect cancer early in blood. The purpose of this study is to collect biological samples from donors with a new diagnosis of cancer (blood and tumor tissue) and from donors who do not have a diagnosis of cancer (blood) in order to characterize the population heterogeneity in cancer and non-cancer subjects and to develop models for distinguishing cancer from non-cancer.
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A Study to Evaluate Exercise for Cancer Patients at Risk of Falling
Rochester, MN
The purpose of this study is to develop a data-driven approach that enables healthcare providers to “prescribe” exercise in the appropriate dose in a manner analogous to prescribing a drug.