Neoplasms

All Conditions

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Behaviors and Mental Disorders

Carcinoma

Neoplasm Metastasis

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Pregnancy Complications

Genital Diseases, Female

Urogenital Diseases

Endocrine Gland Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Neoplasms, Glandular and Epithelial

Female Urogenital Diseases

Female Urogenital Diseases and Pregnancy Complications

Genital Diseases

Adnexal Diseases

Ovarian Diseases

Gonadal Disorders

Urologic Diseases

Neoplasms by Histologic Type

Male Urogenital Diseases

Ovarian Cancer

Quality of Life

Ovarian Epithelial Cancer

Antineoplastic Agents

All Drugs and Chemicals

Pharmaceutical Solutions

Paclitaxel

Albumin-Bound Paclitaxel

Carboplatin

Cisplatin

Ocoxin-Viusid® before, during and after the Chemotherapy treatment.

Ocoxin-Viusid group (Experimental): Oral solution Ocoxin-Viusid (30 ml vials) were used at a rate of 60ml / day (1 vial every 12 hours), preferably administered after breakfast and dinner. The treatment will start a week before start Chemotheray treatment (CT) and, It will maintenance until 3 weeks after finished the last cycle of CT (3 cycles of CT of Carboplatin/Paclitaxel or Cisplatin/ Paclitaxel with neoadjuvant intent).

Ocoxin-Viusid

Our hypothesis is: the nutritional supplement Ocoxin-viusid improves the quality of life of patients, including a better tolerance to neoadjuvant chemotherapy.

General Objectives -To identify the efficacy of the nutritional supplement Ocoxin-viusid to increase the quality of life of patients with epithelial advanced or metastatic ovarian cancer. Specific Objectives - Identify the influence of the research product on the nutritional status and quality of life of patients. - Describe the toxicity of the research product. - Identify the adverse reactions to the chemotherapy scheme and quantify the interruptions to it by acute toxicity.

Quality of life. It will be measured as: - EORTC Questionnaire QLQ-C30 (Score of each item and general score). Measurement time: at the beginning and 3 weeks after the 3rd cycle of QT - EORTC Questionnaire QLQ-OV28 (Score of each item and general score). Measurement time: at the beginning and 3 weeks after the 3rd cycle of QT - Karnofsky index (Score of 0-100 points at intervals of 10). Measurement time: at the beginning, in each cycle of QT and 3 weeks after the 3rd cycle of QT

Evaluation of Ocoxin-Viusid® in Advanced or Metastatic Ovarian Epithelial Cancer

Efficacy of the Oncoxin-Viusid® Nutritional Supplement on the Quality of Life of Patients With Advanced or Metastatic Ovarian Epithelial Cancer. Clinical Trial Phase II.

It will measured by: - EORTC QLQ-C30 (Points of every item and final points)

Karnofsky index (Score of 0-100 points at intervals of 10)

EORTC QLQ-OV28 (Points of every item and final points)

Catalysis SL

Uterine Cervical Neoplasms

Uterine Neoplasms

Uterine Cervical Diseases

Uterine Diseases

An invitation to order a HPV self sampling test through an online application will be sent by SMS or electronic letter.

2019-2021 - A Cobas PCR Female swab sample packet will be sent. Response rates (participation) will be measured.

2022 and onwards - A FLOQSwab and corresponding sample tube for analysis on the BD COR platform will be sent.

Sending of screening summon.

Miriam Elfström, PhD

Helena Andersson, PhD

Viviann Mattsson, MD

Christer Borgfeldt, MD, PhD

Katarina Kylebäck, MD

Mirjam Våtz, Midwife

Hanna Milerad, MD

Lovisa Bergengren, MD, PhD

Prevention of cervical cancer with cervical screening is one of the most successful screening activities in medicine. In Sweden, screening was implemented in the 1960s and has since prevented tens of thousands of women from having cervical cancer. Individual invitations to screening result in increased attendance therefore evaluating strategies for reaching women through invitations is particularly valuable. Women who regularly attend screening following an invitation reduce their risk of cervical cancer by as much as 90%. Of the women who are diagnosed with cervical cancer (about 550 women per year in Sweden), as many as 38% did not participate in the screening. Invitations for screening are sent to the entire population in Sweden aged 23-70. The current coverage of screening is 82.9%, which represents the proportion of women ages 23-70 who attend according to recommendations. In addition, many women are sporadic attenders who reduce their risk for cancer somewhat. The highest cancer risk is seen among those women who have never participated as well as women who have had a history of precancerous lesions or HPV infection but have not been followed-up. Cervical cancer is the first form of cancer for which there are approved molecular screening tests (HPV test). Unlike the older screening method (cytology), self-collected samples can be analyzed for HPV (the analysis method is so sensitive that it does not matter if the sample is not optimally taken).

Invitations and reminders about cervical screening are sent by letter to the woman's home address (about 3 million letters per year in Sweden). This strategy results in a waste of resources and has a negative environmental impact. Regarding reminders, we have seen in previous research that the effect is not optimal. When sending a physical reminder letter to women who have not participated in more than 10 years (current routine), only 2% of the women invited came for sampling. Reminders with SMS are now standard for many businesses in society, such as car testing or dental appointments. It is inexpensive, saves the environment and there are studies that suggest it is more effective than sending physical letters. In this study, we intend to investigate whether SMS reminders, electronic letters, and physical letters for screening lead to increased participation and thus to a higher proportion of detected, treatable precursors of cervical cancer compared to before.

Non-participation in the cervical screening program and sub-optimal follow-up after abnormalities or infection with a highly oncogenic HPV type detected in screening are the main risk factors for cervical cancer. Given this, It is important to reduce barriers to screening and facilitate participation in the screening program of cervical cancer. Offering self-sampling kits for human papillomavirus (HPV) testing has been examined in several research studies as a way to reach women who have not responded to screening invitations. Women who have been lost to follow-up can also be reached with self-sampling.

The purpose of this study is to investigate whether SMS reminders and electronic letters for screening attendance will increase participation compared to the current method where reminders are sent out with physical letters. In this study, women a with high risk of developing cervical cancer, due to not fully participating in screening or being followed up optimally, will be invited. Women are identified through registry linkages annually that examine screening history and status using a risk algorithm. Women receive an SMS or an electronic letter with an offer to request a self-sampling kit via the internet. Women with a higher risk for cervical cancer can be offered a self-sampling kit sent directly to their home address. The self-sampling kit comes with an instruction on how to take the sample and a postage-free answer envelope.

Submitted samples are analyzed with an approved and accredited method (Cobas 4800, Roche) that analyzes for HPV 16, HPV18 and other oncogenic HPV types. As the screening program changed the accredited HPV test in 2022 (to BD Onclarity), that test will be used from the timepoint of the change and onwards.

In the pilot of the study, follow-up is defined as follows:

1. For those women who are at the highest risk (previous glandular cell changes without follow-up), all HPV-positive women are referred via SMS directly to a women's clinic for investigation. HPV-negative women in this group have no increased risk and receive a text message with a calming message.
2. Women of an age above the screening program but who have either had a cell change that is not followed up or who have not participated at all in the last 10 years are treated in the same way as in paragraph 1.
3. Finally, the women of screening age who have not taken a cell sample for more than 15 years are identified. This group receive an SMS and HPV-positive women are referred, via SMS, for renewed sampling by a specially trained so-called dysplasia midwife. The sample is now being analyzed for both cytology and HPV. If the woman is HPV positive in both tests and in the case of deviating cytology, the woman is referred to a women's clinic. In other cases a text message with a reassuring message is sent.

The study has the usual level of confidence (p \<0.05 two-sided) and statistical power (80%) the ability to demonstrate an increase of participation by 3 times or more.

The protocol was piloted in the Region of Skåne in 2019 and then rolled out nationally in 2020.

The study is rolled out nationally with annual linkages to identify women with an excess risk for cervical cancer and an adaptive approach to reaching women with SMS, electronic letters, and physically letters with direct delivery of HPV self-sampling kits or an option to order a self-sampling kid (depending on risk). The study is coordinated centrally and each region has a contact person to whom women who need follow-up are referred.

SMS-based Summons in Cervical Screening

Can SMS-reminders Result in Increased Participation in Cervical Screening?

Participation rate in screening after summons.

Cytologically and histopathologically confirmed percursors of cervical cancer.

Histopathologically confirmed cervical cancers.

Region Skane

Karolinska Institutet

Affiliated Researcher

Respiratory Tract (Lung and Bronchial) Diseases

Digestive System Diseases

Infections

Skin and Connective Tissue Diseases

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma, Squamous Cell

Stomach Neoplasms

Esophageal Neoplasms

Urinary Bladder Neoplasms

Communicable Diseases

Melanoma

Vulvar Neoplasms

Abdominal Neoplasms

Small Cell Lung Carcinoma

Head and Neck Neoplasms

Microsatellite Instability

Gastrointestinal Neoplasms

Epstein-Barr Virus Infections

Carcinoma, Basal Cell

Virus Diseases

Papillomavirus Infections

Nasopharyngeal Carcinoma

Digestive System Neoplasms

Carcinoma, Merkel Cell

Vulvar Diseases

Disease Attributes

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Herpesviridae Infections

DNA Virus Infections

Tumor Virus Infections

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

Stomach Cancer

Esophageal Cancer

Biliary Tract Cancer

Small Cell Lung Cancer

Vulvar Cancer

Merkel Cell Carcinoma

Small Intestine Cancer

Antibodies

Immune Checkpoint Inhibitors

Immunomodulating Agents

Antibodies, Bispecific

Immunoglobulins

Dose Escalation; Intervention: Drug: STAR0602

Dose Expansion; Recommended Phase 2 Dose (RP2D) identified from Phase 1 will be used in Phase 2; Intervention: Drug: STAR0602

STAR0602

Ke Liu, MD, PhD

Guru Sonpavde, MD

Marijo Billusic, MD

Erica Redmond

James Gulley, MD, PhD

Ryan Sullivan, MD

Claire Friedman, MD

Kai He, MD

Lillian Siu, MD

This is an open label, multicenter, phase 1/2 study to assess the safety/tolerability and preliminary clinical activity of STAR0602 as a single agent administered intravenously in participants with advanced solid tumors that are antigen-rich.

This Phase 1/2 study consists of two parts: Phase 1 Dose Escalation and Phase 2 Dose Expansion. In Phase 1 Dose Escalation, STAR0602 will be administered intravenously in participants with advanced solid tumors to assess safety/tolerability profile of STAR0602 and to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of STAR0602. In Phase 2 Dose Expansion, STAR0602 at RP2D will be administered to participants with advanced, antigen-rich solid tumors to further evaluate safety and assess preliminary clinical activity of STAR0602. Clinical activity will be evaluated by objective tumor response rate (ORR), duration of response (DOR), disease control rate (DCR), and progression free survival (PFS).

A Study of a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule STAR0602 in Participants With Advanced Solid Tumors

A Phase 1/2, First-in-Human, Open-Label, Dose Escalation and Expansion Study of STAR0602, a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule, in Subjects With Unresectable, Locally Advanced, or Metastatic Solid Tumors That Are Antigen-rich (START-001)

Complete response (CR) and partial response (PR)

Marengo Therapeutics, Inc.

Analgesics

The web-based app will be used to remind patients of discharge instructions, ask questions related to current prescription pain medication use, new symptoms, or changes in the severity of symptoms. Patients will receive reminders via text or email to use the app. Daily reminders will be sent in Week 1, every other day in Week 2, and once per week for Weeks 3-4. All participants will be followed for a minimum of 30 days and will be asked to complete a baseline survey at enrollment and a follow-up survey scheduled 30 days after hospital discharge.

Patients will have access to the web-based app, but will not receive reminders to use it. All participants will be followed for a minimum of 30 days and will be asked to complete a baseline survey at enrollment and a follow-up survey scheduled 30 days after hospital discharge.

Week 1, Day 1: Click through each discharge instruction; Week 1, Days 2-7: Click through single list of all discharge instructions.

Participants will receive a reminder of discharge instructions everyday for the first week post-discharge.

Discharge instructions reminders

Group will receive reminders to enter new symptoms or changes in symptoms (based on a Likert scale or Y/N) on the following schedule: Week 1 (daily), Week 2 (every other day), Weeks 3-4 (once per week)

Prompts to report symptoms via the web-enabled app

Alerts based on certain response thresholds are generated to inform the patient's care team of any concerning responses or trends that emerge from the patient reported outcomes. These alerts will inform providers of particular patient-related adverse events or symptoms requiring an intervention prior to the point that emergent medical care is needed. Information in the alert emails will include the participant's Medical Reference Number (MRN), initials, date of birth, and details about the symptom(s) that generated the alert. Pod nurses instructed to respond to any clinical alerts (sent via email) as soon as possible following standard of care.

Clinical Alerts

Ilana Graetz, PhD

Purpose: The purpose of this study will be to test the use of a web-based mobile application (app) initiated at the time of hospital discharge to engage and monitor patients in order to efficiently deliver better outcomes. The mobile app will be used to remind patients of discharge instructions, assess adherence treatment regimens, and evaluate symptoms.

Rationale: Approximately 60% of patients with ovarian cancer have advanced stage disease at diagnosis, and thus aggressive surgical procedures are often medically necessary. Recent evidence suggests that nearly one in five patients hospitalized for ovarian cancer surgery will be readmitted within 30 days of discharge. Patients readmitted within 30 days have a 50% increase in one-year mortality rates and significantly increased costs of care. In addition, many of the conditions and complications that led to readmission could potentially have been avoided with more intensive post-surgical follow-up care. Mobile health technologies can effectively and efficiently connect patients with their healthcare team and have been shown to improve treatment adherence and reduce avoidable ER visits and hospitalizations.

The investigators plan to enroll 15 subjects per study arm, for a total of 30 participants. Potential subjects for recruitment will be identified from the electronic health records system of the West Cancer Center. The West Cancer Center employs four physicians specializing in gynecologic oncology who account for nearly 100% of open abdominal hysterectomies among ovarian cancer patients in the region. All four physicians have expressed strong support of the study and have agreed to actively participate by allowing screening of electronic health record data to identify appropriate patients and referral of eligible patients to the Nurse Coordinator for possible consent. The Nurse Coordinator will approach eligible patients during their surgery planning visit or in the hospital prior to surgery to provide an overview of the research study and seek informed consent.

Patients who provide informed consent will immediately be asked to complete a brief baseline survey about their preferences for receiving prompts, either via email or via cell phone using a text message. After survey administration, all patients will be registered in the mobile health app, which will be used provide discharge care instructions and monitor their progress upon discharge. Study participants will then be randomized into one of two arms: 1) active prompts to use the study app or 2) use of study app, but no prompts. All participants will be followed for a minimum of 30 days and will be asked to complete a follow-up survey during a scheduled in-clinic appointment at the end of the study.

Baseline and follow-up questionnaires will collect data on quality of life (SF-12), physical symptoms, activities of daily life, prescription narcotic use, health literacy, demographics and use of health care services (e.g. ER visit, hospital admission, clinic appointment). The web-based app will be used to remind patients of discharge instructions, ask questions related to current prescription pain medication use, new symptoms, or changes in the severity of symptoms.

Data from this study will be derived from the following sources: electronic health data to capture treatment changes and disease severity; responses to baseline and follow-up questionnaires to measure self-reported behaviors, including quality of life, use of prescription pain medication and care utilization; and post-study semi-structured interviews with physicians and patients to provide qualitative feedback.

Post-Operative Gynecological Oncology App Study

Post-Op Gynecological Oncology Web-Based App Study

The primary data analysis will adhere to the intention-to-treat principle and in the final analysis, the participants will be categorized according to their initial randomization. Investigators will measure changes in quality of life from baseline and at 30-days, and compare changes between the two study arms.

Investigators also plan to carry out a secondary analysis, which will adhere to the intention-to-treat principle and in the final analysis, the participants will be categorized according to their initial randomization. Investigators will measure any healthcare utilization within the 30 day post-discharge, and compare utilization between the two study arms.

Investigators also plan to carry out a secondary analysis, which will adhere to the intention-to-treat principle and in the final analysis, the participants will be categorized according to their initial randomization. Investigators will measure participants' independence 30 days post-discharge using an Activities of Daily Living (ADL) assessment adapted from the Katz Index of Independence, and compare status between the two study arms.

University of Tennessee West Cancer Center

University of Tennessee

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of Ocoxin-Viusid® in Advanced or Metastatic Ovarian Epithelial Cancer	NCT03562897	Carcinoma Ovarian Neoplas... Endocrine Gland... Urogenital Neop... Ovarian Disease... Adnexal Disease... Genital Disease... Female Urogenit... Female Urogenit... Endocrine Syste... Gonadal Disorde... Genital Neoplas... Neoplasms, Glan...	Ocoxin-Viusid	18 Years -	Catalysis SL
SMS-based Summons in Cervical Screening	NCT04061967	Cervical Cancer Uterine Cervica... Uterine Neoplas... Genital Neoplas... Genital Neoplas... Uterine Disease... Genital Disease... Neoplasms by Si... Neoplasms Uterine Cervica...	Sending of scre...	33 Years - 75 Years	Karolinska Institutet
A Study of a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule STAR0602 in Participants With Advanced Solid Tumors	NCT05592626	Advanced Solid ... Genital Neoplas... Urogenital Neop... Lung Neoplasm Neoplasms by Si... Papillomavirus ... Epstein-Barr Vi... Carcinoma Neoplasms Vulvar Neoplasm... Vulvar Diseases Abdominal Neopl...	STAR0602	18 Years -	Marengo Therapeutics, Inc.
Evaluation of Ocoxin-Viusid® in Advanced or Metastatic Ovarian Epithelial Cancer	NCT03562897	Carcinoma Ovarian Neoplas... Endocrine Gland... Urogenital Neop... Ovarian Disease... Adnexal Disease... Genital Disease... Female Urogenit... Female Urogenit... Endocrine Syste... Gonadal Disorde... Genital Neoplas... Neoplasms, Glan...	Ocoxin-Viusid	18 Years -	Catalysis SL
Post-Operative Gynecological Oncology App Study	NCT02932098	Genital Neoplas...	Discharge instr... Prompts to repo... Clinical Alerts	18 Years -	University of Tennessee
SMS-based Summons in Cervical Screening	NCT04061967	Cervical Cancer Uterine Cervica... Uterine Neoplas... Genital Neoplas... Genital Neoplas... Uterine Disease... Genital Disease... Neoplasms by Si... Neoplasms Uterine Cervica...	Sending of scre...	33 Years - 75 Years	Karolinska Institutet

Spots Global Cancer Trial Database for genital neoplasm, female