Gland and Hormone Related Diseases

All Conditions

Thyroid Diseases

charlotte demoor-goldschmidt, Dr

charlotte demoor-goldschmidt

florent de vathaire

gerard michel

pascal auquier

The DENACAPST programme represents an important initiative to provide near nation-wide roll-out of an important cancer surveillance program for childhood cancer survivors. The program is based on internationally recognized standards in cancer surveillance, which were developed by the International Guideline Harmonization Group (IGHG) with support of all relevant stakeholders in cancer survivorship research and clinical work in Europe, Canada and the United States and recognized French recommendations about breast screening for women at high risk of cancer.

With this programme, French centers organized themselves to provide to childhood cancer survivors adequate medical attention, which includes close medical surveillance for breast/thyroid cancer where appropriate, based on adequate risk stratification.

The aim of the study is to analyze if the recommendations about breast and thyroid cancer screening are followed in this population and secondly to provide more informations about these second cancers and about the screening.

Every center which has patient at risk can participate. Main inclusion criteria : French childhood cancer survivor (5 years or more of delay with the treatment) - becoming adult - with a past history of radiotherapy at the age of 20 years or before, with a significant dose irradiation on the thyroid or the breast

The inclusion of patients are validated by one team

Thyroid screening programme is based on US each 2 years Breast screening programme is based mainly on MRI each year

National Breast and Thyroid Screening After a Treatment Received Against a Cancer During Childhood

number of persons at risk found percentage of persons at risk contacted who answered percentage of persons contacted, who answered, who accepted the screening

evaluated by auto-questionaries :initial / final and comparison with persons who accepted to answer but who did not accept the screening

Institut National de la Santé Et de la Recherche Médicale, France

Herbal and Botanical

All Drugs and Chemicals

Grape

After 4 week run-in period, drink 6 ounces of purple grape juice twice daily, then 4 week washout, week 12 drink 6 ounces of clear apple juice for 4 weeks twice daily

After 4 week run-in period, drink 6 ounces of clear apple juice twice daily, then 4 week washout, week 12 drink 6 ounces of purple grape juice for 4 weeks twice daily

6 ounces of purple grape juice consumed twice daily either during first or second 4 week supplementation period, depending on sequence randomization

Purple Grape Juice

6 ounces of clear apple juice consumed twice daily either during first or second 4 week supplementation period, depending on sequence randomization

Apple Juice

Cindy K Blair, MPH

Rationale: Survivors of childhood cancer are at an increased risk of developing cardiovascular risk factors as well as early cardiovascular disease, likely due to the intensive therapeutic regimen used to treat their cancer. Purple grape juice (PGJ) is a rich source of flavonoids and a powerful antioxidant. Clinical studies in both diseased and healthy adults suggest that daily consumption of PGJ contributes to increased antioxidant capacity, reduced low-density lipoprotein (LDL) oxidation, and improved vasodilation.

Purpose: This randomized clinical trial is evaluating whether purple grape juice can reduce oxidative stress and improve the vascular health of survivors of childhood cancer in the early stages of cardiovascular disease.

Primary Objective:

* To evaluate the effect of PGJ on endothelial function, a key measure of vascular health and considered a barometer for cardiovascular disease risk.

Secondary Objective:

* To evaluate the effect of PGJ on biomarkers of vascular and systemic oxidative stress.

Outline:

Patients undergo a 4-week washout period and refrain from consuming any type of juice, juice drink (less than 100% juice), wine or grapes. Patients are then randomized to 1 of 2 arms.

Arm 1: Beginning in week 4, patients consume 6 ounces of purple grape juice (PGJ) twice daily for 4 weeks. Beginning in week 12, after a 4 week washout period, patients crossover to consume apple juice (AJ) as in Arm 2.

Arm 2: Beginning in week 4, patients consume 6 ounces of AJ twice daily for 4 weeks. Beginning in week 12, after a 4 week washout period, patients crossover to consume PGJ as in Arm 1.

Purple Grape Juice in Improving Vascular Health in Childhood Cancer Survivors

A Pilot Study to Evaluate the Effects of Purple Grape Juice on the Vascular Health of Childhood Cancer Survivors

Difference of least square means (95% Confidence Interval) in RH-PAT Index Scores between juice groups. Higher RH-PAT scores indicate better endothelial function; a positive difference of least square means is suggestive of an improvement in endothelial function.

Probes were placed on the index fingers of both hands and a blood pressure cuff was placed on one arm. The cuff was inflated to suprasystolic pressure and the digital pulse volume was recorded before, during \& after a 5 minute occlusion period. The ratio of the hyperemic and the baseline pulse amplitude (corrected for the same ratio on the control finger) was calculated and expressed as the RH-PAT index score. Lower scores reflect worse endothelial function.

Change from baseline in Oxidized LDL at 4 weeks, a biomarker of oxidative stress

Change from baseline in Myeloperoxidase (MPO) at 4 weeks, a biomarker of oxidative stress

Change from baseline in high sensitivity C-Reactive Protein (hs-CRP) at 4 weeks, a biomarker of inflammation

University of Minnesota

6 ounces of grape juice consumed twice daily in either the first or second intervention period

6 ounces of clear apple juice consumed twice daily in either the first or second intervention period

Includes groups randomized to receive purple grape juice first and apple juice first

Entire Study Population

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Measured in kilograms at beginning of study.

Weight

Measured in centimeters are beginning of study.

Height

Measured in kilograms/m\^2 at beginning of study.

Body Mass Index

Systolic blood pressure

Diastolic blood pressure

Fasting glucose

Fasting insulin

Low-density lipoprotein (LDL) Cholesterol

High-density lipoprotein (HDL) Cholesterol

Triglycerides

Cindy K. Blair, MPH

Change in Endothelial Function (Reactive Hyperemia Peripheral Arterial Tonometry (RH-PAT) Index Score)

Change in Oxidized LDL

Arm 2 Apple Juice Then Purple Grape Juice

Change in Myeloperoxidase (MPO)

Change in High Sensitivity C-Reactive Protein (Hs-CRP)

Arm 1: 6 ounces of grape juice twice daily during first 4 weeks of intervention (intervention period 1) followed by a 4 week washout period followed by 6 ounces of clear apple juice twice daily during 4 weeks (intervention period 2).

Arm 1 Purple Grape Juice Then Apple Juice

Arm 2: 6 ounces of clear apple juice twice daily during first 4 weeks of intervention (intervention period 1) followed by a 4 week washout period followed by 6 ounces of purple grape juice twice daily during 4 weeks (intervention period 2).

First Intervention

Washout Period

Second Intervention

Heart and Blood Diseases

Hypertension

Prehypertension

Vascular Diseases

Participants randomly assigned to this group will be instructed to measure their blood pressure (BP) every day during the 3-month study period. BP reading will be taken using an iHealth Wireless Blood Pressure Monitor.

Participants randomly assigned to this group will be instructed to measure their BP for seven consecutive days once each month during the 3-month study period. BP reading will be taken using an iHealth Wireless Blood Pressure Monitor.

Participants will be provided with an iHealth Wireless Blood Pressure (BP) Monitor and instructions for proper use (based on a standard protocol). The iHealth device pairs easily with a cell phone or other mobile device equipped with the iHealth app (freely available on app stores for both Apple and Android devices). Participants place the cuff on their arm and press start on their mobile device. The device measures BP using the oscillometric method and automatically downloads measurements and timing to a cloud-based server.

Participants will be educated that individual BP readings can be highly variable and that any one high or low reading has little or no significance. They will also be encouraged not to measure their blood pressure more than twice in the morning and twice in the evening.

iHealth Wireless Blood Pressure Monitor

Todd M. Gibson, PhD

Second malignant neoplasms and cardiac late effects are primary drivers of serious non-recurrence morbidity and mortality in long term childhood cancer survivors. Cardiac late effects have been most prominently associated with exposure to high doses of anthracyclines or chest radiation. While increased recognition of late effects has resulted in risk-targeted therapy and reductions in use of high dose radiation and anthracyclines for many patients, these cardiotoxic exposures continue to be essential components of curative childhood cancer therapy. In addition, as survivors age they are increasingly susceptible to other general risk factors for cardiovascular disease recognized in the general population, such as hypertension, obesity, dyslipidemia, and diabetes.

This study will evaluate a high blood pressure monitor (HBPM)-based intervention for the early detection of pre-hypertension and prevention of clinical hypertension in survivors of childhood cancer. Eligible and consenting participants will be randomized into one of three groups:

GROUP 1: Instructed to measure blood pressure (BP) every day for 3 months. GROUP 2: Instructed to measure BP for 7 consecutive days once a month, for 3 months.

GROUP 3: Instructed to measure blood pressure for 3 consecutive days each month, for 3 months.

The randomization to the above groups will be done using sequential assignment of newly recruited participants based on a randomly ordered list.

PRIMARY OBJECTIVE:

* Evaluate the feasibility of High Blood Pressure Monitoring (HBPM) for three consecutive months using a remote blood pressure device provided to participants of the St. Jude Lifetime cohort (SJLIFE) protocol.

SECONDARY OBJECTIVES:

* Assess compliance with use of HBPM by measurement frequency, evaluating overall and defined minimum use in each of the three different groups.
* Assess compliance with use of HBPM by cell phone status, evaluating those with and without a personal cell phone capable of connecting directly to the home blood pressure monitoring device via Wi-Fi or Bluetooth network.

The proposed research and testing being done during this study includes:

1. Screening evaluation and consent - Individuals will be asked questions to help the investigators determine if they are eligible to participate. This includes questions about medical history pertaining to blood pressure, medicines, and certain medical conditions, and if the individuals are willing to use the technology provided by the study. For individuals who are eligible to participate, an opportunity will be provided to discuss the study and complete the consent process.
2. Group assignment and randomization - Participants will be randomly assigned to one of three groups: a study team member will select one of sixty identical envelopes, each containing a group assignment, with 20 envelopes containing each of the three group assignments. This random group assignment determines the frequency with which participants will monitor their blood pressure at home. The randomization between three different groups will help investigators determine how often survivors can consistently monitor their blood pressure.
3. Educational session - After participants have been assigned to a group, they will be instructed on how to set up and use the home blood pressure monitoring device.
4. Monitoring blood pressure at home - Participants will be asked to monitor their blood pressure at home in the morning and evening using a remote monitoring device over a three-month period. Frequency of monitoring depends on the random group assignment. The device is the iHealth Wireless Blood Pressure Monitor which is a wireless blood pressure monitoring device that fits snugly around one arm and automatically measures and records blood pressure in about one minute. The device will be paired with the participant's smart phone or study-provided iPod Touch, which is then used to operate the device and save the blood pressure readings. After completion of the three-month monitoring period, participants will be asked to return the device (and iPod Touch, if applicable).
5. Reminders to use the device - Participants are to start monitoring their blood pressure when they return home after completion of their St. Jude visit. During the educational session, participants will be asked to set up reminders on their smart phone or study-provided iPod Touch to alert them to monitor their blood pressure. Depending on how often they are assigned to monitor their blood pressure, they may also receive email and/or text reminders to prompt them to monitor their blood pressure. In addition, a study team member may contact them if they have three or more measurements above 140/90 mm Hg, as that reading is considered hypertensive. A study team member may contact participants if they are not monitoring as specified by their group assignment to attempt to troubleshoot any barriers and/or technical issues.

Assessing Blood Pressure Remotely in Childhood Cancer Survivors

Feasibility of Assessing Blood Pressure Remotely in Childhood Cancer Survivors (Pilot Study-Survivor)

The proportion of participants who meet or exceed the defined minimum level of compliance with recording of scheduled blood pressure measurements will be reported. Minimum use is defined as:

Groups 1 and 2: Successful recording of 12 measurements (maximum 2 per day, one morning and one evening) over any 7 day period in at least 2 of the 3 months of the study.

Group 3: Successful recording of two measurements each day (morning and evening) for three consecutive days, at least once in each of the 3 months of the study.

The overall compliance rate for each group will be calculated as the number of measurements recorded divided by the number of measurements scheduled.

Calculations will be done for participants who own a smart phone compatible with the HBPM device compared to those who need to be supplied with an additional device to pair with the HBPM device. The overall compliance for each group will be calculated as the number of measurements recorded divided by the number of measurements scheduled.

St. Jude Children's Research Hospital

Transition of follow-up care of childhood cancer survivors to adult care

Transition model

Katrin Scheinemann, MD

Maria Otth, MD

Sibylle Denzler, MD

Tamara Diesch, MD

Bernhard Eisenreich, MD

The Aftercare of Childhood Cancer Survivors in Switzerland (ACCS) study is a multicenter cohort study designed to investigate transition of follow-up care from pediatric oncology to adult care in a prospective and longitudinal way. The investigators collect data on preferences and expectations for follow-up care and transition to adult care by questionnaires in adolescent and young adult survivors of childhood cancer.

Background: Every year over 300 children and adolescents up to the age of 18 years are newly diagnosed with cancer in Switzerland. Survival after childhood cancer has increased substantially over the last decades and 10-year survival now exceeds 85%. This results in an increasing numbers of childhood cancer survivors - currently around 7,000 survivors in Switzerland. Due to cancer treatment or the cancer itself, a large part of the childhood cancer survivors suffers from late effects. Early diagnosis and intervention can reduce morbidity and mortality due to late effects. Therefore, regular follow-up care, even beyond childhood, is very important, but transition from pediatric to adult follow-up care is a critical point. In Switzerland there are very different aftercare and transition models, although it is unclear which aftercare strategy is the best and meets the needs of survivors. The Aftercare of Childhood Cancer Survivors (ACCS) study aims to fill this gap.

Objectives: The main objective of the ACCS study is to identify the current needs of adolescent and young adult long-term survivors in terms of follow-up care by comparing three different transition practices. The secondary objective is to assess survivors' knowledge on their diagnosis, therapy and follow-up examinations longitudinally.

Methods: ACCS is a multicenter questionnaire-based study, including survivors from three pediatric oncology centers in Switzerland. Eligible survivors who already transitioned to adult care at start of the study once receive a letter explaining the purpose of the study, the study information, the informed consent form, and the questionnaire. The questionnaire asks about cancer knowledge and additionally includes validated scales on cancer worry, self-management skills, ongoing care, and expectations. The survivors send the documents back by a prepaid envelope. Eligible survivors before transition to adult care at start of the study receive a letter explaining the purpose of the study, the study information and informed consent form, and the first questionnaire two to four weeks before the next scheduled follow-up visit. They can either send the documents back before the visit or bring them to the visit. The participants receive three month after the visit a short questionnaire to assess cancer knowledge. Three month after the follow-up visit after transition (15 month after last visit in pure pediatric setting), the participants receive the first comprehensive questionnaire again.

Rationale and significance: There are very different aftercare and transition models in Switzerland, although it is unclear which follow-up care strategy best meets the needs of survivors. The data collected within the ACCS study helps to define which transition and follow-up care strategies and related factors are favoured by adolescent and young adult survivors. Adaption of transition processes to the needs of survivors improve adherence to follow-up care of adult childhood cancer survivors. As late effects increase with increasing time from treatment, adult survivors of childhood cancer are at particular risk to develop late effects and it is important that they continue follow-up care.

Aftercare of Childhood Cancer Survivors in Switzerland

Aftercare of Childhood Cancer Survivors in Switzerland - the ACCS Switzerland Project

Assessment via validated "Cancer Worry Scale"

Assessment via validated "Self-Management Skill Scale"

Assessment via validated "Scale for ongoing Care"

Assessment via validated "Expectation Scale"

University Children's Hospital Basel

Luzerner Kantonsspital

Kantonsspital Aarau

Division Head of Pediatric Oncology-Hematology

Neoplasms

Rare Diseases

Medulloblastoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Medulloblastoma, Childhood

Neuroepithelioma

Medulloblastoma survivors, 30 between the ages of 12-20 years and 30 between 21-30 years.

Health comparison group frequency matched on age (30 between the ages of 12-20 years and 30 between 21-30 years), gender and race.

Tara M. Brinkman, PhD

Survivors of pediatric medulloblastoma (MB) are at-risk for neurocognitive and social deficits, including specific skills such as facial affect recognition which is the ability to recognize the emotional expressions of another person. Because the underlying mechanisms of these deficits are poorly understood, the investigators propose to examine social-cognitive skills (i.e. facial affect recognition) and indices of brain integrity, including an established core neural network of face perception in MB survivors and healthy controls. By comparing these outcomes between survivors of MB and healthy controls, investigators seek to identify the areas of the brain that help individuals recognize emotions.

Primary Objective:

* To evaluate social cognition in adolescent and young adult survivors of pediatric medulloblastoma.

Secondary Objective:

* To examine indices of brain integrity and function and their association with facial affect recognition in survivors of pediatric medulloblastoma.

Comprehensive social-cognitive and behavioral data will be collected and structural and functional brain imaging will be completed in an attempt to determine if disruptions to brain integrity and function caused by prior treatment of medulloblastoma directly influence social-cognition and behavior in survivors. These outcomes will be compared between survivors and age-, gender-, and race-matched healthy community controls.

Participants who meet eligibility criteria and consent will undergo neurocognitive (intelligence, attention, memory, processing speed, motor, executive function, and visuospatial) and social cognitive evaluations (affect recognition, prosody, social memory, withdrawal/isolation, loneliness, social anxiety, visuospatial, and executive function). Functional magnetic resonance imaging (fMRI) will be completed during affect identification tasks to assess activation of the core face perception network. Magnetic resonance with diffusion tensor imaging (DTI) will be obtained to quantify water diffusion within white matter tracts to assess white matter integrity and its association with functional outcomes.

Social Cognition and Brain Integrity in Survivors of Pediatric Medulloblastoma

Mean scores on measures of facial affect recognition will be compared between survivors of medulloblastoma and age, sex, and race matched community controls.

Means scores on measures of visual spatial processing and executive function will be compared between survivors of medulloblastoma and age, sex, and race matched community controls.

Patterns of brain activation (i.e. hemodynamic responses) will be compared between survivors of medulloblastoma and age, sex, and race matched community controls.

Indices of white matter integrity (e.g., radial diffusivity, axial diffusivity) will be compared between survivors of medulloblastoma and age, sex, and race matched community controls.

St. Baldrick's Foundation

Participants will be prompted to complete questionnaires.

Mobile Health is a multi-featured app designed to enable participants to self-record and track their health and wellness. Participations will set up a profile and complete questionnaires. The app also records the amount of time and features of programs accessed.

Mobile Health App

Kathy Ruble, RN, PhD

The purpose of this research study is to understand if a mobile app is useful to assist young adult female survivors of childhood cancer in the self-management of survivorship-related needs.

Survivorship related needs include managing lingering symptoms from treatment, how to keep a healthy lifestyle, social and medical issues, as well as other needs. The mobile health app that will be used in this study is the Health Storylines TM app developed by Self Care Catalysts Inc. The app can be used for an unlimited amount of time over nine months, which is how long the study will be conducted. The use of the Health Storylines TM app in this study is investigational.

Participation in this study starts with setting up a study specific profile on the app and entering information including email address, age, ethnicity/race, cancer diagnosis, as well as other optional information for the profile (example health goals or current health conditions). Participants will then be prompted by the app to complete three questionnaires about their ability to self-manage their survivorship-related needs, their perception of their survivorship-related illness symptoms and perceived health related quality of life. They will be prompted on the app to complete these questionnaires again at the 3, 6 and 9 month intervals of using the app. It will take about 20 minutes to complete the questionnaires at each measurement time. The only additional information that will be reported from the app for the study is the amount of time and features of programs accessed during the study period.

This project is a longitudinal one-group pilot study evaluating the use of a Mobile Health (mHealth) app intervention. This study will examine: 1) the amount/type of usage, 2 ) compliance with study evaluations and 3) the association of this mHealth app use with perceived self-efficacy in managing survivorship related needs, perceived health illness and health related quality of life. The study period will be nine months, with four measurement points to assess the study's outcomes: baseline, three, six, and nine months post initiation of the mHealth app.

Assessing the Acceptability of the Use of a Mobile Health App Among Young Adult Female Survivors of Childhood Cancer

Assessing the Acceptability of the Use of a Mobile Health App Among Young Adult Female Survivors of Childhood Cancer: A Feasibility Study

Assess the feasibility of the mHealth app as measured by tracking all activities of the patient-centered mHealth health tracking app, Health StorylinesTM, in young adult female survivors

Assess the adherence to study procedures including baseline and follow-up assessments as measured by completion rates of required tasks

Determine the association between the amount of usage (in minutes), the frequency of usage number of times accessed) of the Health StorylinesTM mhealth app, and self-efficacy in young adult female survivors of childhood cancer.

Determine the association between the amount of usage (in minutes), the frequency of usage number of times accessed) of the Health StorylinesTM mhealth app and health related quality of life in young adult female survivors of childhood cancer

Determine the association between the amount of usage (in minutes), the frequency of usage number of times accessed) of the Health StorylinesTM mhealth app and perceived illness in young adult female survivors of childhood cancer.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
National Breast and Thyroid Screening After a Treatment Received Against a Cancer During Childhood	NCT03183401	Early Detection...		18 Years -	Institut National de la Santé Et de la Recherche Médicale, France
Purple Grape Juice in Improving Vascular Health in Childhood Cancer Survivors	NCT01043939	Cardiovascular ...	Purple Grape Ju... Apple Juice	10 Years - 30 Years	University of Minnesota
Assessing Blood Pressure Remotely in Childhood Cancer Survivors	NCT02476162	Hypertension	iHealth Wireles...	18 Years -	St. Jude Children's Research Hospital
Aftercare of Childhood Cancer Survivors in Switzerland	NCT04284189	Childhood Cance... Survivorship Transition	Transition mode...	16 Years -	Kantonsspital Aarau
Social Cognition and Brain Integrity in Survivors of Pediatric Medulloblastoma	NCT02747576	Medulloblastoma		12 Years - 30 Years	St. Jude Children's Research Hospital
Purple Grape Juice in Improving Vascular Health in Childhood Cancer Survivors	NCT01043939	Cardiovascular ...	Purple Grape Ju... Apple Juice	10 Years - 30 Years	University of Minnesota
Aftercare of Childhood Cancer Survivors in Switzerland	NCT04284189	Childhood Cance... Survivorship Transition	Transition mode...	16 Years -	Kantonsspital Aarau
Assessing the Acceptability of the Use of a Mobile Health App Among Young Adult Female Survivors of Childhood Cancer	NCT03242200	Childhood Cance...	Mobile Health A...	18 Years - 30 Years	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
National Breast and Thyroid Screening After a Treatment Received Against a Cancer During Childhood	NCT03183401	Early Detection...		18 Years -	Institut National de la Santé Et de la Recherche Médicale, France
National Breast and Thyroid Screening After a Treatment Received Against a Cancer During Childhood	NCT03183401	Early Detection...		18 Years -	Institut National de la Santé Et de la Recherche Médicale, France

Spots Global Cancer Trial Database for childhood cancer survivor