Phase 2 N=9 Treatment of Oral Premalignant Lesions With 5-ALA PDT
Leukoplakia · Erythroplakia
Primary: Maximum Tolerated Dose — 8 J/cm2
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Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 2 N=133 Treatment of High-Grade Pre-Neoplastic Cervical Lesions (CIN 2/3)
Cervical Intraepithelial Neoplasia · Cervical Dysplasia
Primary: Incidence of Objective Response — 32; 36; 30; 0 Participants — p=0.043
Early Phase 1 N=13 Topical Fluorouracil and Imiquimod in Treating Patients With High-Grade Cervical Intraepithelial Neoplasia
Cervical Intraepithelial Neoplasia Grade 2/3 · Cervical Squamous Cell Carcinoma In Situ · Cervical Squamous Intraepithelial Neoplasia 2
Primary: Feasibility of Intravaginal Use 5-FU and Imiquimod on Alternating Weeks in Women With Biopsy Confirmed High Grade Cervical Squamous Intraepithelial Lesions. — 4; 1…
Phase 2 N=147 Safety and Efficacy of A-007 Topical Gel in the Treatment of High-Grade Squamous Intraepithelial Lesions (HSIL) of the Cervix
Cervical Intraepithelial Neoplasia · Uterine Cervical Dysplasia
Primary: Pathological Response — 20; 24 participants
N/A N=93 Methylation of p16 CpG Island And Malignant Transformation of Oral Epithelial Dysplasia
Oral Epithelial Dysplasia, Mild or Moderate Grade
Primary: The Number of Participants With Both Clinical and Histological Evidence of Malignant Transformation of Oral Epithelial Dysplasia — 32; 46 participants
N/A N=467 HPV Test-and-Treat-Strategy Versus Cytology-based Strategy for Prevention of CIN2+ in HIV-Infected Women
HIV-1 Infection
Primary: Cumulative Rate of Cervical Intraepithelial Neoplasia (CIN2+) (CIN2, CIN3 or Invasive Cancer) by Week 130 — 24.9; 26.5 Events per 100 persons
Phase 2 N=19 Cetuximab in Treating Patients With Precancerous Lesions of the Upper Aerodigestive Tract
Head and Neck Cancer · Precancerous Condition
Primary: Number of Participants With Objective Response Based on Histologic Grade — 13; 6 Participants
Phase 2 N=70 Treatment of Anal High-grade Squamous Intraepithelial Lesions (HSIL) Through Use of a Chinese Herbal Topical Cream
Anus Neoplasms
Primary: Final Response of Anal High-grade Squamous Intraepithelial Lesions (HSIL) — 3; 0; 7; 3 participants — p=.042
Phase 2 N=41 Clinical Evaluation of Bioadhesive Gels for Oral Cancer Chemoprevention
Squamous Cell Carcinoma of Mouth · Intraepithelial Neoplasia
Primary: Light Microscopic Histologically Scored Diagnoses Pretreatment to Post Treatment — 2.36; 2.83; 1.9; 2.58 unit on histologic grade scale — p=0.048
Phase 2 N=130 Celecoxib in Treating Patients With Cervical Intraepithelial Neoplasia
Cervical Carcinoma · Cervical Intraepithelial Neoplasia Grade 2/3 · Stage 0 Cervical Cancer
Primary: Histologic Regression — 40; 34.1 percentage of participants
N/A N=122 Detection Of Neoplastic Tissue in Barrett's Esophagus With In vivO Probe-based Confocal Endomicroscopy
Barrett Syndrome · Barrett's Syndrome · Barrett's Esophagus
Primary: Comparative Histopathology-confirmed Measures of Per Lesion Sensitivity and Per Lesion Specificity, by Using pCLE Associated With WLE, or WLE Alone, for the Detection of…
N/A N=1,111 Helping Patients and Providers Make Better Decisions About Colorectal Cancer Screening
Cancer Screening Tests
Primary: Number of Participants Who Completed Colorectal Cancer Screening — 110; 95; 113; 113 Participants
Phase 2 N=262 Dose-finding Study of Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) to Treat Cervical Neoplasia
Cervical Intraepithelial Neoplasia
Primary: Comparison of Lesion Response Rates of Three Different Doses of HAL PDT and Placebo at 3 Months After Treatment. — 95; 69; 63; 57 percentage of patients
N/A N=63 A Randomized Study of Sulindac in Oral Premalignant Lesions
Leukoplakia, Oral · Benign Neoplasms
Primary: - To Evaluate the Efficacy of Sulindac in Subjects With Early or Advanced Oral Premalignant Lesion (OPL) by Both Clinical Response (Reduction in Size of All Lesions) and…
N/A N=269 Complete Histologic Resection of Adenomatous Polyps?
Adenomatous Polyps
Primary: Percent of Incompletely Resected Adenomatous Polyps — 10.1 percentage of incomplete resection
Phase 2 N=23 Phase II A Trial of Curcumin Among Patients With Prevalent Subclinical Neoplastic Lesions (Aberrant Crypt Foci)
Healthy, no Evidence of Disease · Tobacco Use Disorder
Primary: Baseline in Prostaglandin E2 (PGE2) Within Aberrant Crypt Foci (ACF) — 1.1; 3.4 µg/g protein
N/A N=379 Thermocoagulation for Treatment of Precancerous Cervical Lesions
Human Immunodeficiency Virus · HPV Infection · CIN 2/3
Primary: Proportion of Participants With no Evidence of Cervical Dysplasia at 12-months — 0.66 proportion of participants
Phase 2 N=12 Preventing Squamous Cell Skin Cancer
Squamous Cell Carcinoma of the Skin
Primary: Mean Number of Squamous Cell Carcinomas — 0.75; 1.00 # of squamous cell carcinomas — p=0.750
N/A N=45 Coherence Imaging of the Cervical Epithelium With Scanning a/LCI
Cervical Dysplasia
Primary: Sensitivity of Scanning a/LCI Probe to Detect Cervical Dysplasia as Measured by Percentage of Correctly Identified Positive Biopsies — 90.3; 100.0 percentage of correct…
Phase 2 N=37 Confocal Endoscopic Microscopy for Detection of Early Stage Gastric Cancer in Subjects With Hereditary Diffuse Gastric Cancer Syndrome
Gastric Cancer · Gastric Neoplasms
Primary: Percentage of Participants With Detectable Confocal Endoscopic Microscopy (CEM) w/Greater Sensitivity for Detection of Signet Ring Cells (SRC)Foci in Cadherin-1 (CDH1)…
N/A N=804 Narrow-Band Imaging Versus Standard White Light for the Detection of Serrated Lesions in the Proximal Colon
Colon Cancer
Primary: Total Number of Serrated Lesions Proximal to the Sigmoid Colon — 204; 158; 95; 59 Serrated Lesions
N/A N=75 Warning Signs of Squamous Cell Carcinoma and Prevention of SCC by at Risk Organ Transplant Recipients
Squamous Cell Carcinoma
Primary: Number of Control and Intervention Participants on Skin Self-examination Performance at Follow-up 1 Month After Intervention — 34; 8 Participants
Phase 3 N=5,060 Randomized Clinical Trial on Clinical Management of ASCUS and LSIL (ALTS)
Cervical Intraepithelial Neoplasia
Primary: Percentage of Participants With Cervical Intraepithelial Neoplasia III (CIN III) — 10.93; 10.25; 10.84 percentage of participants
N/A N=130 An Innovative Treatment for Cervical Pre Cancer
Cervical Intraepithelial Neoplasia
Primary: Mean Depth of Necrosis Achieved With the LMIC-adapted CryoPen and the Thermocoagulator Compared to Mean Depth of Necrosis Achieved With CO2-based Cryotherapy — 6.0; 5.6…
Phase 2 N=195 Phase II Randomized Trial of Bethesda Protocol Compared to Cambridge Method for Detection of Early Stage Gastric Cancer in CDH1 Mutation Carriers
Gastric Cancer · Gastric Neoplasms · Gastric Adenocarcinoma
Primary: Proportion of Participants With Improved Sensitivity for Detection of Early-stage Gastric Cancer in CDH1 Germline Mutation Carriers Compared to the Cambridge Method — 1…
N/A N=9 Use of High-Resolution Microendoscopy (HRME) in Patients With Adenocarcinoma In-Situ (AIS) of the Cervix
Cervix Carcinoma
Primary: Feasibility of Acquiring In-vivo High-Resolution Microendoscopy (HRME) Images of Cervix Prior to Conization
Phase 2 N=132 Bowman-Birk Inhibitor Concentrate in Preventing Cancer in Patients With Oral Leukoplakia
Lip and Oral Cavity Cancer · Oral Leukoplakia · Oropharyngeal Cancer
Primary: Relative Percent Change in Total Lesion Area After 6 Months on Study — -20.6; -17.1 percentage change
N/A N=340 Natural History and Management of Pancreatic Lesions in Von Hippel-Lindau Disease
Von Hippel-Lindau Disease
Primary: Number of Patients With Pancreatic Lesions Defined by Simple Cysts, Microcystic Adenomas, Neuroendocrine Tumors & Other Solid Lesions of the Pancreas Who Had Significant…
Phase 3 N=46 Confocal Endomicroscopy for Barrett's Esophagus
Barrett's Esophagus · Esophageal Adenocarcinoma
Primary: Diagnostic Yield for Neoplasia in High Risk Patients(Suspected Neoplasia) — 34; 17 percent yield for neoplasia — p=0.01
N/A N=164 CLE for Assessment of Neoplasia After Mucosal Ablation or Resection of Gastrointestinal Neoplasia
Barrett Syndrome · Barrett's Syndrome · Barrett's Esophagus
Primary: Number of Barrett's Esophagus (BE) Participants With a Composite Outcome of "Optimally Treated" — 16; 16 participants