
Cervical And Self-Sample In Screening Study
Cervical CancerIntraepithelial NeoplasiaThe proposed study seeks to compare the diagnostic performance of Human Papillomavirus (HPV) testing in self-collected samples via the Eve Medical self-collection system© (Eve) with standard physician-collected samples for the detection of cervical intraepithelial neoplasia grade 1 or worse (CIN1+) and cervical cancer among women referred for colposcopy. The performance of the Eve sample will also be compared with that of a second self-sample via a cobas® PCR Female swab. Approximately 1000 adult women with an abnormal Pap test at the level of an atypical squamous cells of undetermined significance or worse squamous or glandular abnormality (i.e., ASCUS+) or an abnormal co-test (ASCUS+ and HPV-positive) result will be recruited over a period of 12 months via colposcopy clinics located at the Jewish General Hospital, St-Mary's Hospital, and the McGill University Health Centers (Royal Victoria Hospital). Participating women will undergo three cervical or cervicovaginal sampling techniques: 1) self-sampling using the Eve Medical self-collection system©; 2) self-sampling using a cobas® PCR Female swab; and 3) physician-collected sampling. The participants will also fill in a questionnaire on their experience with the convenience and acceptability of the Eve system, relative to the other two sampling approaches. The decision as to which self-sample is to be collected first will be dependent on randomization HPV testing will be done using the cobas® 4800 HPV Test. The liquid medium of within the cobas® PCR CELL Collection Media with the provider collected sample and the cobas® PCR media with the two self-collected samples will be used to suspend the cellular material prior to HPV testing. We have made collaborative arrangements with Dr. Marcel Behr, Chief of the Department of Clinical Microbiology at the McGill University Health Centre for the HPV genotyping work. Histology-confirmed CIN1+ will form the study outcome or case definition. Sensitivity, specificity, and predictive values (along with their respective 95% confidence intervals) will be calculated for each sample type to evaluate the clinical performance of the various sampling techniques. We will use CIN1+ as definition of disease but analyses will also be performed for more stringent definitions, e.g. CIN2+ or CIN3/cancer.

E7 TCR T Cell Immunotherapy for High-Grade Cervical Intraepithelial Neoplasia
Cervical Intraepithelial NeoplasiaBackground: Human papillomavirus (HPV) can lead to High-Grade Cervical Intraepithelial Neoplasia (CIN 2,3). This type of lesion has a high risk of becoming cancer. T cells are part of the immune system. A new type of treatment involves modifying these cells and injecting them into the lesions to shrink them. Objective: To test if injecting a type of treatment directly into cervical lesions can be safely given as therapy for high-grade CIN. Eligibility: People ages 21 and older with CIN 2,3 caused by HPV-16 Design: Participants will be screened over at least 2 visits with: Tumor sample Blood and urine tests Medical and medication history Physical exam Pelvic exam and colposcopy to look at the cervix Participants will have a baseline visit. They may be admitted to the hospital. They may receive a large catheter inserted into a vein. They will have a vein assessment. Before they receive treatment, participants will have a biopsy of the cervix. They will have leukapheresis. Blood will be removed through a needle in the arm, circulated through a machine that takes out the while blood cells, then returned through a needle in the other arm. A central catheter may also be used. Participants will have the modified cells injected directly into their cervical lesions. They will recover in the hospital for 1-2 days. Participants will have follow-up visits 2 weeks, 31 days, 6 weeks, and 12 weeks after treatment. They may receive a second injection at the 31-day visit. Participants will be contacted once a year for 5 years after treatment. They will be followed for up to 15 years.

Prediction of Upgrade to Invasive Cancer in Patients Diagnosed With Ductal Carcinoma in Situ by...
CarcinomaDuctal3 moreIt is considered that whether or not the accompanying invasive cancer classified through MRI images of breast cancer patients identified as Ductal Carcinoma in situ (DCIS) through preoperative tissue biopsy is significantly consistent with the postoperative stage. Therefore, this study intend to evaluate the effectiveness as a diagnostic tool that can help determine the axillary lymph node surgery by predicting the possibility of post-operative up-staging using magnetic resonance imagings of breast cancer patients who have been identified as ductal carcinoma in situ and are scheduled for surgery.

Breast-Conserving Surgery Followed by Radiation Therapy With MRI-Detected Stage I or Stage II Breast...
Ductal Breast Carcinoma in SituEstrogen Receptor-negative Breast Cancer14 moreRATIONALE: Breast-conserving surgery is a less invasive type of surgery for breast cancer and may have fewer side effects and improve recovery. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II clinical trial is studying how well breast-conserving surgery followed by radiation therapy works in treating patients with stage I or stage II breast cancer.

A Phase I Prevention Study of Atorvastatin in Women at Increased Risk for Breast Cancer
Atypical Ductal Breast HyperplasiaBreast Cancer2 moreChemoprevention is the use of certain drugs to keep cancer from forming. The use of atorvastatin (Lipitor) may prevent breast cancer. This randomized phase I trial is studying the best dose of atorvastatin in preventing breast cancer in women at increased risk for breast cancer.

Celecoxib in Treating Patients With Cervical Intraepithelial Neoplasia
Cervical CarcinomaCervical Intraepithelial Neoplasia Grade 2/31 moreThis randomized phase II trial studies how well celecoxib works in treating patients with cervical intraepithelial neoplasia, a precancerous lesion of the cervix which can develop into cervical cancer. Celecoxib may be effective in preventing the development of cervical cancer in patients who have cervical intraepithelial neoplasia.

Study of SOR007 Ointment for Cervical Intraepithelial Neoplasia (CIN)
Cervical Intraepithelial NeoplasiaThis is a Phase 2, open-label, dose-rising study evaluating the safety, tolerability, and preliminary efficacy of three concentrations of SOR007 ointment (0.15%, 1.0%, and 2.0%) applied topically once per week for four weeks to the ectocervix of subjects with high grade cervical intraepithelial neoplasia (CIN).

Broccoli Sprout Extract in Preventing Recurrence in Patients With Tobacco-Related Head and Neck...
HNSCCHead and Neck Cancer6 moreThis study is being done to see whether Avmacol®, a dietary supplement made from broccoli sprout and seed extract powder, induces changes in inner cheek cells that may be protective against environmental toxins such as tobacco. There are three main goals of the study: To learn whether the dietary supplement, Avmacol®, can stimulate cheek cells to repair damage from environmental toxins; to learn how the body metabolizes Avmacol®, by measuring its byproducts in the participant's urine and blood; to learn whether the immune system can be stimulated by Avmacol®, by studying the natural killer cells and T cells in the participant's blood.

An Efficacy Study of the Xoft® Axxent® eBx® IORT System® "Lite"
Invasive Ductal CarcinomaDuctal Carcinoma In SituThe purpose of this trial is to assess the efficacy of the Xoft Axxent eBx System when used for single-fraction IORT in early stage breast cancer. A comparison will be made to the current standard of care, whole breast irradiation (WBI), in women with early stage breast cancer.

Early Detection of High Grade Ovarian Cancer Using Uterine Lavage EHUD Study and Duplex Sequencing...
Ovarian Epithelial CancerCarcinoma in Situ1 moreIn Phase I the sponsor will systematically test conditions for lavage filtration that increase tumor cell fraction without reducing tumor mutation yield. The Sponsor will also transition all lavages to luteal phase timing, when endometrial shedding is least. In Phase II the Sponsor will examine our data in context of clinical characteristics, particularly age, to develop a multivariate model that determines optimal mutant allele frequency (MAF) diagnostic threshold by patient. Furthermore, the sponsor will explore a highly innovative idea, entailing empirically determining each individual's background mutation load, agnostic of the aging or mutagenic exposures responsible, and using this as a personalized calibrator to determine optimal MAF diagnostic threshold.