Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Digestive System Diseases

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Uterine Cervical Neoplasms

Carcinoma

Colorectal Neoplasms

Breast Neoplasms

Calculi

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

All women aged 50-69 years attending breast cancer screening in the intervention unit on an intervention day. They will all be offered to receive information on their screening status in cervical cancer og colorectal cancer screening.

Women aged 50-64 years, who have not had a cervical cytology sample taken within 5 years and 6 months will be offered to receive a self-sample device for high risk human papilloma virus (hrHPV) screening by mail, or reminded to see her general practitioner (GP) to have a conventional cervical cytology sample taken.

Women aged 50-69 years, who have not had a Faecal Immunochemical Test (FIT) within 2 years and 4.5 months will be offered to receive a new self-sampling kit for FIT.

Women in the control group will receive standard screening offers according to the national screening programme.

Women are offered check-up on screening status in both CCU and CRC screening. If a woman is not up to date in one or both screening programmes, she will be offered a self-sampling device and/or a FIT kit.

Screening status

Berit Andersen, Prof., MD, Head of Department

The overall aim of the study is to increase participation rates in cervical cancer (CCU) and colorectal cancer (CRC) screening programmes in Denmark by offering home-based CCU and CRC screening to women who are overdue for one or both screening programmes when attending breast cancer screening

A cluster-randomised public health trial will take place in Central Denmark Region (CDR) targeting women attending breast cancer screening. Five breast cancer screening units serve women five days a week, and all five units will be included in the study and randomly allocated to an equal amount of intervention days. On the intervention days, the other four units will serve as the control group, providing a randomisation ratio of 1:4.

On the intervention days, a research assistant will ask the women aged 50-69 years if they are interested in having a check up on their screening status with CCU and CRC screening. If the woman has not participated timely, she will be offered to receive a test-kit corresponding to CRC screening and/or to receive a self-sample device for CCU screening (or reminded to call her general practitioner (GP) to have a conventional cervical cytology sample taken).

If the woman accepts a self-sample kit for CCU and/or CRC screening, she will receive it by mail together with written instructions, picturebased user instructions, information on national recommendation for cancer screening and a pre-paid, pre-addressed envelope for returning the sample to the laboratory.

The result of the test will be sent to the women by digital mail as well as passed on to her GP.

Clinical management in case of a positive test result will follow national guidelines corresponding to CCU and CRC screening programmes.

Women in the control group will receive standard screening offers according to the national screening programmes.

All women entering a breast cancer screening unit in CDR on a intervention day (intervention + control units) will be sent a survey asking their experience with breast cancer screening a few days after breast cancer screening. The women in the intervention group will be asked about the acceptability of the intervention as well.

27500 women must be included, of which 5500 women will be in the intervention group.

Three Birds With One Stone

Three Birds With One Stone: a Randomised Intervention Study to Increase Participation in Cervical and Colorectal Cancer Screening Among Women Attending Breast Cancer Screening

Process outcome within the intervention group

Evaluation regarding the acceptability of the intervention

Difference in overall coverage og CCU/CRC screening six months after the intervention between control and intervention group

Difference between intervention and control group in proportion of women participating in CCU and CRC screening after 180 days for those overdue with CCU/CRC screening at the intervention

A GP collected sample after a hrHPV positive self-sample

"Under-screened" defined as screened at least once with in the last 10 years prior to the intervention. "Un-screened" defined as no screening sample with in the last 10 years prior to the intervention.

"Under-screened" defined as at least one FIT, but none with the last 2 years and 4.5 months. "Un-screened" defined as no previous FIT despite invitation

University of Aarhus

Antineoplastic Agents

All Drugs and Chemicals

Cisplatin

Cisplatin two (2) one-time weekly intravenous infusions at 40 mg/m2 (70mg maximum)

IMRT once daily, four fractions per week for 2 weeks 4.56 Gy x 8 fractions

High dose rate Brachytherapy twice per week with a 2-day break in between sessions for a total of four brachytherapy treatments. The dose is 7 Gy x 4 fractions

A total of two IV infusions of cisplatin will be administered on Day 1 and again on Day 8 +/- 1 day. Cisplatin starting dose is 40 mg/m2. Dose reduction is allowed (30 mg/m2) as needed for management of toxicities.

given once daily Monday-Thursday, four fractions per week for 2 weeks. The radiation dose is 4.56 Gy x 8 fractions.

intensity modulated radiation therapy (IMRT)

administered 2x weekly (allow at least 72-hours window between sessions); weekdays only for 2 weeks. The radiation dose is 7 Gy x 4 fractions.

high-dose-rate (HDR) brachytherapy

Yvonne Taul, RN

Denise Fabian, MD

The goal of this clinical trial is to investigate the use of hypofractionated radiation (delivery of fewer but larger doses of radiation) with concurrent chemotherapy for women with metastatic of bulky uterine cervix cancer. The main questions it aims to answer are:

* What is the MRI-assessed rate of response at 1-month and 3-months post-treatment?
* What is the safety and tolerability of cisplatin-based hypofractionated pelvic Intensity Modulated Radiation Therapy (IMRT) followed by brachytherapy?
* What is the median progression-free survival and overall survival at 1 and 2 years for patients who undergo cisplatin-based hypofractionated pelvic IMRT?
* What is the proportion of patients who complete the treatment in prescribed timeframe?
* What the levels of cervix cancer circulating tumor cells pretherapy and after treatment?

To confirm eligibility, within four weeks prior to study enrollment, all patients will undergo the following:

* Complete history and physical exam, GOG performance status evaluation
* Standard of care scans, which include staging CTs and/or PET scans, and MRI to verify eligibility and appropriate stage of disease. Blood tests will be done to check various organ functions.

Treatment will be administered on an outpatient basis.

The main difference between the proposed regimen in the trial and standard of care is as follows:

1. The trial has a shortened course of EBRT. Standard of care utilizes 25 treatments, also known as "fractions" of EBRT, while the trial utilizes 8 fractions of EBRT. An equivalent "biological effective dose" is achieved by increasing the radiation dose per fraction.
2. The concurrent cisplatin dosing is shortened from 5-6 cycles of cisplatin to 2 cycles of cisplatin. The dose of cisplatin is 40 mg/m2.

This protocol requires photon IMRT technique followed by high dose rate (HDR) brachytherapy. The therapies use focused energy beams to kill cancer cells. Radiation therapy must be completed within 30 days +/- 2 days of initiation. Computed tomography simulation with the patient in a head-first laying on back-supine position is required. MRI-guided treatment planning and image guidance during treatment for motion management will be used.

IMRT will be given once daily Monday-Thursday, four fractions per week. The high-dose-rate (HDR) brachytherapy following institutional protocol. Brachytherapy will be delivered twice per week with a 2-day break in between sessions. A total of four brachytherapy treatments will be delivered.

After active therapy is completed, treatment-related toxicity will be assessed at the 1-month post-treatment completion visit and again at the 3-month post-treatment completion. Patients removed from the study for unacceptable adverse events will be followed until resolution or stabilization of the adverse event(s).

Routine MRI imaging to assess treatment response to radiotherapy is conducted at Day 15. Treatment response to radiotherapy followed by brachytherapy will be assessed at the 1- month and 3-months post-treatment completion.

Following the 3-months post-treatment completion, study participants will be followed for disease progression and survival status until Year 2 post-treatment initiation. NOTE: Cervical cancer patients are routinely followed (clinical surveillance) every 3-months during the first two years post-treatment.

Hypofractionated Radiochemotherapy

Phase II Trial of Hypofractionated Radiochemotherapy for Women With Metastatic or Bulky Uterine Cervix Cancer

A total of 15mL of peripheral venous blood will be collected for Circulating tumor cells (CTC). Counts will be reported as means with standard deviations in tabular format

MRI-assessed rates of complete response as estimated by the number of CRs (complete response per RECIST v1.1) divided by the total number of evaluable subjects

The proportion of complete response will be assessed at 3-mos post-treatment completion, i.e., Day 120, as estimated by the number of CRs (complete response per RECIST v1.1) divided by the total number of evaluable subjects.

Progression-free survival (PFS) is calculated from the date of treatment start (week 1, day 1) to the date of initial disease progression or to the date of death or to 2-years post-treatment initiation, whichever occurs first.

Overall Survival is calculated from the date of treatment start until date of death or up to 2-years post-treatment initiation, whichever occurs first.

reported as a proportion of subjects who complete entire prescribed course of the treatment based on the treatment compliance for Radiotherapy and for Cisplatin

Assessed by Common Terminology Criteria for Adverse Events (CTCAE v4.0)

Denise Fabian

Assistant Professor

Anti-Infective Agents

Nelfinavir

HIV Protease Inhibitors

Protease Inhibitors

Enzyme Inhibitors

Anti-HIV Agents

Anti-Retroviral Agents

Antiviral Agents

Fiona Simpkins, MD

Lilie Lin, MD

Patients 18 years of age and older with clinical stages IIA, IIB, IIIA, IIIB, IVA cervical carcinoma limited to the pelvis will receive twice daily oral nelfinavir (NFV) and weekly IV cisplatin in combination as radiosensitizers with daily whole pelvic external beam and intracavitary radiation brachytherapy.

A Study of Nelfinavir Added to Cisplatin Chemotherapy Concurrent With Pelvic Radiation for Locally Advanced Cervical Cancer (II-IVA)

A Phase I Study of Nelfinavir Added to Cisplatin Chemotherapy Concurrent With Pelvic Radiation for Locally Advanced Cervical Cancer (II-IVA)

Abramson Cancer Center at Penn Medicine

Rare Diseases

Uterine Cervical Dysplasia

Precancerous Conditions

Cervical Intraepithelial Neoplasia

The participants randomized to the intervention group will be exposed to the patient liaison in receiving their colposcopy report results and recommendations. Rather than receive results from their referring/family physician, an experienced colposcopy nurse will contact participants once the colposcopists complete the final colposcopy report. The colposcopy nurse will provide an explanation of the colposcopy results and subsequent follow-up or treatment recommendations, be available to answer patient questions (within her scope), offer educational or support resources to patients.

The control group will receive the standard of care for colposcopy results reporting via their referring physician. Following their colposcopy visit, control patients are given a slip of paper reminding them to call their family/referring physician for their colposcopy results in three weeks if they have not yet been contacted. Upon receipt of the final pathology, colposcopy reports are prepared by the colposcopists and forwarded to family/referring physicians typically within 2-3 weeks of the visit. Patients then receive the results of their colposcopy report from their family/referring physician by whatever method of communication preferred by that provider.

An experienced colposcopy nurse will contact participants once the colposcopists complete the final colposcopy report. The colposcopy report will inform the referring provider that these patients will be informed of the results. The colposcopy nurse will provide an explanation of the colposcopy results and subsequent follow-up or treatment recommendations, be available to answer patient questions (within her scope), offer educational or support resources to patients. She will forward any patient questions beyond her scope to the patient's colposcopist who may then provide answers to the patient liaison or to the patient directly depending on the complexity and nature of the question.

Patient Liaison

Marette Lee, MD/MPH/FRCSC

This study is intended to improve the patient experience of communication of colposcopy results and follow-up recommendations to patients. Current practice involves results being forwarded from the colposcopy clinic to the family or referring physician who then informs the patient. We are testing an intervention informed by focus groups in which a trained colposcopy nurse (patient liaison) directly contacts patients with their results and follow-up recommendations while providing education and support. We will examine whether this intervention improves patient satisfaction, reduces anxiety, and improves rates of adherence to follow-up and treatment appointments compared to the current practice.

Cervical cancer is the second most commonly diagnosed cancer and third leading cause of cancer death in women worldwide. Pre-cancerous cells can be detected with regular Pap smear screening and diagnosed and treated with colposcopy. This process is limited by patient adherence to the follow-up and treatment recommendations. Currently at Vancouver General Hospital (VGH), the largest colposcopy clinic in the province, results are forwarded from the colposcopy clinic to the family or referring physician who informs patients of results and recommendations. Inefficiencies or errors in this step may cause patient dissatisfaction, missed appointments, increased costs, and compromise patient outcomes. The primary objective of this study is to examine whether having a trained colposcopy nurse directly contact patients with their results and follow-up recommendations while providing education and support will improve patient satisfaction and reduce anxiety, with the secondary aim being to assess the clinical effectiveness of this intervention in improving rates of adherence to follow-up and treatment appointments and potentially long-term clinical outcomes. The first phase of the study involves patient focus groups that will be interviewed about what elements of a patient liaison interaction are most important (separate Ethics submission). This information will inform the development of the patient liaison role and approaches to patient interaction to be utilized in the intervention in the second phase. The second phase will entail a randomized controlled trial comparing patient anxiety, satisfaction and adherence to follow-up between a control group (current practice) versus the intervention group exposed to the patient liaison at the VGH Colposcopy Clinic. For the primary aim, a questionnaire containing items pertaining to patient anxiety and satisfaction with their experience of receiving their colposcopy results will be administered both to the intervention and control groups and the mean scores pertaining to anxiety and satisfaction will be compared using two-tailed t-tests. For the secondary aim, a chart review at 6-12 months following the initial colposcopy visit will examine the rates of compliance with the recommended follow-up or treatment visits and histologic diagnoses, and comparisons will be sought between the intervention and control groups using z-score test.

The SAFE Study: Satisfaction and Adherence to Follow-Up With Colposcopy Exams

Mean state anxiety scores as measured by the State Trait Anxiety Inventory (STAI) State Subscale. The STAI has 40 items with 20 items allocated to each of the State Anxiety and Trait Anxiety subscales. Responses for the State Anxiety scale assess intensity of current feelings from 1-4 "at this moment": 1) not at all, 2) somewhat, 3) moderately so, and 4) very much so. Item scores are added to obtain subtest total scores and for anxiety-present items, a higher score suggests higher anxiety. Scoring is reversed for anxiety-absent items (items in which a higher score suggests lower anxiety). Range of scores for the subscale is 20-80 with a higher score indicating greater anxiety. A cut point of 39-40 has been suggested to detect clinically significant symptoms for the State Anxiety scale.

Patient satisfaction scores as measured by items in the questionnaire drawn from the Visit Specific Satisfaction Instrument (VSQ-9) Inventory. The VSQ-9 is a 9 item survey that measures patient satisfaction with access to primary care, with the direct interaction with the physician, and with the visit overall on a scale ranging from 1 (poor) to 5 (excellent). To score the VSQ-9, responses from each individual are transformed linearly to a 0 to 100 scale, with 100 corresponding to "excellent" and 0 corresponding to "poor" (0= Poor, 25= Fair, 50= Good, 75= Very Good, 100= Excellent). The 9 responses are then averaged together to create a VSQ-9 overall score for each person, again with 100 being the best evaluation and 0 the poorest.

Satisfaction with information and education received regarding colposcopy, patient diagnosis and follow-up recommendations measured by questionnaire items that measure these factors (PSQ-18 Inventory). This inventory contains 18 items assessing each of the 7 dimensions of satisfaction with medical care (general satisfaction, technical quality, interpersonal manner, communication, financial aspects, time spent with doctor, accessibility and convenience). Each item is scored from 1-5. Some PSQ-18 items are worded so that agreement reflects satisfaction with medical care, whereas other items are worded so that agreement reflects dissatisfaction with medical care. All items all scored so that high scores reflect satisfaction with medical care. All items are then summed; sum score of all items may range from 18 to 90 points, where 18 points is the poorest evaluation and 90 points the best.

The percent of patients who correctly report their colposcopy pathologic diagnosis

Percentage of patients who attended follow-up at the colposcopy clinic

British Columbia Cancer Agency

Women's Health Research Institute of British Columbia

University of British Columbia

Program Director, BC Provincial Colposcopy Program

The intervention is delivery of colposcopy results. The highest risk serious adverse event (with associated mortality risk) would be failure of colposcopy results delivery leading to failure to receive treatment for cervical dysplasia or carcinoma which may lead to a delay or absence of appropriate treatment with associated morbidity or mortality.

The participants randomized to the intervention group will be exposed to the patient liaison in receiving their colposcopy report results and recommendations. Rather than receive results from their referring physician, an experienced colposcopy nurse will contact participants once the colposcopists complete the final colposcopy report.

Patient Liaison: An experienced colposcopy nurse will contact participants once the colposcopists complete the final colposcopy report. The colposcopy report will inform the referring provider that these patients will be informed of the results. The colposcopy nurse will provide an explanation of the colposcopy results and subsequent follow-up or treatment recommendations, be available to answer patient questions (within her scope), offer educational or support resources to patients. She will forward any patient questions beyond her scope to the patient's colposcopist.

Patient Liaison Intervention

Control

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

297 consenting women \>18 years old presenting for initial appointment at the study colposcopy clinic were randomized.

Although 152 participants were randomized to the control group, 3 withdrew post-randomization and only 149 were included in the analysis (thus, a total of 294 participants were included in the analysis).

Small number of subjects analyzed overall, small number of patients completing questionnaire in the control group

Dr. Marette Lee

Anxiety

Quantitative Satisfaction With Colposcopy Visit Experience Including Interactions With Colposcopy Professionals

Satisfaction With Colposcopy Information and Diagnosis Education

Patient Knowledge of Own Colposcopy Diagnosis

Adherence to Colposcopy Treatment and Follow-up Instructions

Overall Study

Standard daily radiotherapy plus weekly cisplatin followed by brachytherapy

Standard

Yvonne Taul

This is a phase 0 clinical trial of molecular biomarkers in women with uterine cervix cancer. Women receive standard-of-care radiochemotherapy followed by brachytherapy. Blood samples are obtained to detect circulating levels of deoxyribonucleotides, human papillomavirus DNA, and circulating tumor cells.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Three Birds With One Stone	NCT05022511	Uterine Cervica... Uterine Cervix ... Uterine Cervica... Colorectal Neop... Colorectal Canc... Colorectal Carc... Mass Screening Early Detection...	Screening statu...	50 Years - 69 Years	University of Aarhus
Hypofractionated Radiochemotherapy	NCT06331468	Uterine Cervix ...	Cisplatin intensity modul... high-dose-rate ...	18 Years - 120 Years	University of Kentucky
A Study of Nelfinavir Added to Cisplatin Chemotherapy Concurrent With Pelvic Radiation for Locally Advanced Cervical Cancer (II-IVA)	NCT02363829	Uterine Cervix ...	Nelfinavir Cisplatin	18 Years -	Abramson Cancer Center at Penn Medicine
A Study of Nelfinavir Added to Cisplatin Chemotherapy Concurrent With Pelvic Radiation for Locally Advanced Cervical Cancer (II-IVA)	NCT02363829	Uterine Cervix ...	Nelfinavir Cisplatin	18 Years -	Abramson Cancer Center at Penn Medicine
The SAFE Study: Satisfaction and Adherence to Follow-Up With Colposcopy Exams	NCT03296566	Uterine Cervica... Uterine Cervix ...	Patient Liaison	19 Years -	University of British Columbia
Clinical Trial of Molecular Biomarkers in Women With Uterine Cervix Cancer	NCT05462951	Uterine Cervix ...	Standard	18 Years -	University of Kentucky

Spots Global Cancer Trial Database for uterine cervix cancer