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Uterine Cervical Neoplasms clinical trials

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NCT ID: NCT04995809 Active, not recruiting - Clinical trials for Uterine Cervical Neoplasms

Effect of Pelvic Radiotherapy on the Intestinal Microbiome and Metabolome

EPRIMM
Start date: June 25, 2021
Phase:
Study type: Observational

Eight in ten patients will develop bowel problems during radiotherapy, eg diarrhoea, pain and incontinence, half will develop difficult long-term bowel problems. It is not known why some people get bowel problems and others do not and there is no test to predict who will develop bowel problems following their treatment. There is a link between the changes in the number and type of gut bacteria (the microbiome) in some bowel conditions and it is possible to test for these different bacteria in a simple stool sample using genetic testing. Also gut bacteria produce different gases in the stool called "volatile organic compounds" (VOCs), which can be measured in stool samples. Specific VOC patterns have been seen in other bowel conditions and small studies suggesting that there are specific VOC and gut bacteria patterns in the stool of those undergoing pelvic radiotherapy which may help to identify people who will get difficult bowel problems. Diet can change the microbiome/VOCs so diet change could improve bowel symptoms after radiotherapy. The investigators would like to test stool samples of patients with womb, cervix or bladder cancer having pelvic radiotherapy to see if there are differences in the number/type of gut bacteria and VOCs between those who get severe bowel symptoms compared to those with mild bowel symptoms. They also want to see whether these differences in VOCs or gut bacteria can tell who will develop severe bowel symptoms during or after radiotherapy and determine the effect of diet. The first step is to run the study on a small scale to confirm that a larger study would work. This will make sure the investigators can recruit and consent people safely and will test the best ways of measuring bowels symptoms using several questionnaire options. They will collect the information needed to work out how many people would be needed in a large trial to fully test the theory. Ultimately, the investigators would like to use differences in the number/type of gut bacteria and VOCs to find ways to better prevent and treat bowel problems after pelvic radiotherapy.

NCT ID: NCT04947605 Active, not recruiting - Clinical trials for Uterine Cervical Neoplasms

Epidemiological Landscape of Cervical Cancer in Latin America

EVITA LATAM
Start date: November 4, 2021
Phase:
Study type: Observational [Patient Registry]

A portrait of clinical and epidemiological aspects of cervical cancer in Latin America is required to understand the high frequency of cervical cancer despite the existence of effective preventive tools. A better understanding of the current situation of this scenario will provide a valuable groundwork for the development of national and cooperative programs to improve cervical cancer prevention and treatment.

NCT ID: NCT04870177 Active, not recruiting - Gynecologic Cancer Clinical Trials

Study of AK112 in the Treatment of Advanced Gynecological Tumors

Start date: March 16, 2021
Phase: Phase 2
Study type: Interventional

A phase II study to evaluate the efficacy and safety of AK112 in subjects with advanced gynecological tumors.

NCT ID: NCT04716127 Active, not recruiting - Cervical Cancer Clinical Trials

A Proximity-incentive Strategy for Cervical Cancer Screening

RIDECA
Start date: September 16, 2021
Phase: N/A
Study type: Interventional

In France, cervical cancer screening is based on a cervical smear for women aged 25 to 30 years and on High Risk- HPV (HR-HPV) testing for women aged 30 to 65 years. One of the main concerns in France is poor attendance to this screening program, up to 40% of women, which led French Health Authorities to implement population-based organized cervical cancer screening (DO CCU), based on remind letters, starting in 2019. Our project is a complementary strategy to DO CCU based on direct proposal of a vaginal self-sample device for HR-HPV testing to non-attendee women while attending health care centers. Our hypothesis is that contacting under-screened women directly and proposing them a self-sample device to be used at home will increase their participation to cervical cancer screening. This project will be held in the Departments of Hérault and Aude, which are among those in the region of Occitanie (south of France) with the lowest participation to cervical cancer screening. Women aged 50 to 65 years with no cervical smear and/or gynecological examination for more than three years, will be recruited in two sites: in a mobile unit for breast cancer screening implemented in the whole Department of Hérault and in a Medical and Social Care located in a particularly deprived area of Aude (Limoux-Quillan). In each site, non attendee-women will be proposed by a trained mid-wife, a vaginal self-sample device to perform at home and send back by mail to the laboratory of the Hospital of Montpellier, which will perform HR-HPV testing. Women with positive HR-HPV DNA test will be asked to perfom a cervical smear and completion of follow-up will be monitored. The primary objective of this study will be to evaluate attendance of under-screened women to vaginal self-sampling for cervical cancer screening, i.e. the number of women who accepted a self-sample device among women to whom it has been proposed. A second objective will be to analyse psycho-social factors associated with cervical cancer screening in this population of non-attendee women, i.e. their socio-economic environment and the way women perceive and are implicated in cervical cancer screening. This secondary objective will be based on a specific questionnaire at recruitment and on semi-directive phone interviews in a sub-group of women. The efficacy of this screening strategy (number of women who performed vaginal self sample and sent it to the laboratory, and number of women who completed follow-up in case of a positive HR-HPV test) will also be monitored. The number of women to be recruited is 300 for each site. The total estimated duration of the project is 48 months, including 24 months for women's recruitment. Expected results from this project are: - An increase in participation to cervical cancer screening of non-attendee women aged 50 to 65 years in the Departments of Hérault and Aude. - Women's education about cervical cancer screening through discussion with the midwife during recruitment and information tools developed for the project - Information of local health staff and community-based associations about cervical cancer screening and the place of HR-HPV testing. - Identification of psycho-social factors and potential barriers to compliance to cervical cancer screening. - Identification of organizational and practical difficulties that must be overcome to improve preventive actions towards deprived populations.

NCT ID: NCT04697628 Active, not recruiting - Cervical Cancer Clinical Trials

Tisotumab Vedotin vs Chemotherapy in Recurrent or Metastatic Cervical Cancer

innovaTV 301
Start date: February 22, 2021
Phase: Phase 3
Study type: Interventional

This trial is being done to find out whether tisotumab vedotin works better than chemotherapy to treat cervical cancer. People in this study have cervical cancer that has spread to other parts of the body (metastatic) or has come back after being treated (recurrent). Participants in this trial will be randomly assigned to one of two groups. One group will be treated with tisotumab vedotin. Participants in the other group will get one of five different chemotherapy drugs (topotecan, vinorelbine, gemcitabine, pemetrexed, or irinotecan). Participants and their doctors will know which group they are in. Participants in the chemotherapy group will decide with their study doctor which drug they will take.

NCT ID: NCT04689178 Active, not recruiting - Cervical Cancer Clinical Trials

Cervical Cancer Screening Uptake: A Randomised Controlled Trial Assessing the Effect of Sending Invitation Letters to Nonadherent Women

IMPACTGP
Start date: January 8, 2021
Phase: N/A
Study type: Interventional

Context: In France, cervical cancer (CC) screening was opportunistic until recently. The target population includes women aged 25 to 65 years. About 66% of women aged 25-40 years have performed a screening test over the last three years but this figure decreases to 55% in women over 40. The third "Cancer Plan" proposed by the French National Institute for Cancer recommends to achieve an 80% participation in eligible women. Improving women compliance to CC screening is a major challenge to decrease cancer incidence and mortality. To improve patient adherence, a CC screening organization will be launched in 2020 at a national scale in France. Women who did not perform a PAP test over the last 3 years will receive an invitation letter from the local public health association in charge of cancer screening organization. The invitation letter will remind women that they should consult a healthcare professional (a general practitioner (GP), a gynecologist or a midwife) to perform a screening test. Providing GPs with a list of their non-adherent patients could also improve women compliance to CC screening recommendations. The study objective is to assess whether sending both an invitation letter to non-adherent women and a list of their non-adherent patients to GPs ("invitation letter + GP reminder" group) could increase the proportion of women who perform a screening test, compared to only sending an invitation letter to non-adherent women ("invitation letter" group) or not sending any invitation ("usual care" group).

NCT ID: NCT04683549 Active, not recruiting - Cervical Cancer Clinical Trials

HPV Serum Level and FDG PET CT in Patients With Cervical Cancer Treated With Radical Radiochemotherapy

HPV-RICCO
Start date: June 15, 2020
Phase: N/A
Study type: Interventional

The main purpose of the study is to describe changes in plasma HPV DNA levels in patients with locally advanced cervical cancer during radical radiochemotherapy (CRT) and to correlate changes with response to treatment. Monitoring of the response to treatment will also be assessed in FDG PET CT imaging.

NCT ID: NCT04680988 Active, not recruiting - Clinical trials for Recurrent or Metastatic Cervical Cancer

A Study of SHR-1210± SHR-1020 Versus Chemotherapy in Patients With Recurrent or Metastatic Cervical Cancer

Start date: April 5, 2021
Phase: Phase 2
Study type: Interventional

This is a randomized, open-label, 3-arm Phase 2 study to evaluate the efficacy and safety of SHR-1210 alone or with SHR-1020 versus physician's choice chemotherapy in recurrent or metastatic cervical cancer patients. All enrolled patients will be randomly divided into 3 groups and receive treatment until disease progression, intolerable toxicity,any criterion for stopping the study drug or SHR-1210 treatment for up to 2 years.

NCT ID: NCT04670445 Active, not recruiting - Clinical trials for Stage IV Breast Cancer

Improving Patient and Caregiver Understanding of Risks and Benefits of Immunotherapy for Advanced Cancer

UPLIFT
Start date: January 23, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to refine and pilot test educational material developed to educate and support patients receiving immunotherapy for advanced cancer. The intervention is an educational video and question prompt list (QPL) to promote communication between patients, caregivers, and the oncology team about the risks and benefits of immunotherapy.

NCT ID: NCT04664985 Active, not recruiting - Vaginal Disease Clinical Trials

Evaluation of Mucogyne® Ovule in Vulvovaginal Dryness Management in Women Treated by Brachytherapy and/or Radiotherapy for Endometrial or Cervical Cancer.

HYDRAMUC
Start date: October 6, 2020
Phase: N/A
Study type: Interventional

Randomized, open-label, national (France), multicenter, prospective clinical study, to evaluate the superiority of Mucogyne® ovules over the control group on vaginal health (including hydration) in women treated by brachytherapy and/or radiotherapy for endometrial or cervical cancer.