Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Skin Neoplasms

Distribution of the sun protection educational workbook

Distribution of general skin care information

Subjects will read a workbook about sun protection

Workbook

June K. Robinson, M.D.

This study is being done to evaluate the effectiveness of a Sun Protection Strategies workbook for kidney transplant recipients. Since the medication taken to preserve the kidney transplant puts kidney transplant recipients at an increased risk of developing skin cancer. The program will help people learn about how to practice effective sun protection after the transplant.

Cognitive interview about the Sun Protection Strategies workbook will be performed with up to 25 kidney transplant recipients (KTR) who have participated in past surveys. A second phase of the study involves 156 KTRs that will be asked to take part in a randomized controlled trial evaluating the fully developed sun protective strategies workbook.

Kidney transplant recipients (KTRs) are at risk to develop skin cancer. Adequate sun protection after transplantation can reduce the risk of developing skin cancer. In 2006, the National Kidney Foundation (NKF) found that sun protection education delivery and content varied among transplantation centers. Clinicians rarely knew when to initiate education about skin cancer risks and prevention including timing and scope, and rarely demonstrated understanding of the importance of reminders for and repeated education of patients (National Kidney Foundation 2006).

Aims:

1. To explore culturally sensitive use of terms describing ethnic cultural perceptions of sun burning, pigment darkening after sun exposure and description of skin color by the amount of photo-protective pigment in the skin.
2. To pilot test the sun protection workbook with English speaking KTRs representing the 3 ethnic groups: White, Black and Hispanic.
3. To assess the effectiveness of an education intervention encouraging the use of sun protection strategies.
4. To explore understanding of the importance of sun protection and the KTRs confidence in their being able to practice sun protection.

Evaluation of Sun Protection Education for Kidney Transplant Recipients

Subjects will complete self-report surveys of behavior prior to educational intervention and 6- 8 weeks after the educational intervention

Northwestern University

Principal Investigator

Renal transplant patients with first cancer (all cancer excepting skin cancer including in group 2).

Intervention : blood sample

Renal transplant patients without cancer matched for age, transplantation duration and CMV/EBV status.

Intervention : blood sample

Patient with cancer from oncology departement matched for cancer type and stade and CMV/EBV status.

Renal transplant patients with first epidermoid skin cancer. Intervention : blood sample

Renal transplant patients with several epidermoid skin cancer. Intervention : blood sample

Renal transplant patients without cancer matched for age, transplantation duration and CMV/EBV status with renal transplant patients with skin cancer.

Intervention : blood sample

Blood sample

Emilie Gaiffe, Dr.

Ingrid Tissot

Didier Ducloux, Pr.

As early complications of transplantation (acute rejection and infections) were better controlled and that the survival of kidney transplants has increased, chronic complications of immunosuppression became increasing challenges. The incidence of cancer is greatly increased in transplant and cancer is now the first cause of death. The iatrogenic immunosuppression plays a major role in the increased incidence of cancer. If it is accepted that the incidence of cancer is generally increased after transplantation, the increased risk is very different from a specific cancer to another. Furthermore the specific treatment of the tumor (surgery, radiotherapy, chemotherapy, biotherapy), the specificity of the context of transplantation is related to the possibility of modulation of immunosuppression. However, there is no immunological marker for predicting the effectiveness of a modification of the immunosuppression.

Several studies point to the important role of CD4 T cells into Th1 anti-tumor immunosurveillance group cancers. Identified "helper" degenerate peptides, called Universal Cancer Peptide (UCP) derivative of telomerase, a type of tumor antigen universal. These UCP peptides bind most HLA-DR alleles most frequent of the population and have the particularity of specifically stimulate CD4 T cells of type Th1. Using a test based on the UCP, it possible to detect the presence of spontaneous CD4 Th1 anti-UCP answers in several types of human cancers.

The main objective of this study is to determine whether, in renal transplant patients, the occurrence of cancer is associated with a deficiency of CD4 Th1 response anti-hTERT.

Study of Specific CD4 Tumors Th1 Responses in Renal Transplant After Occurrence of Cancer

Th1 anti-hTERT cell levels measured in blood by IFN-γ ELISpot in renal transplant patients developing cancer versus first with renal transplant patients without cancer.

Th1anti-hTERT cell levels measured in blood by IFN-γ ELISpot in patients developing a first or recurrent squamous cell carcinoma compared with renal transplant patients without cancer.

University Hospital, Lille

University Hospital, Tours

Centre Hospitalier Universitaire de Besancon

Distribution of the internet-based sun protection educational program.

Distribution of general skin care information.

Prior to summer, KTRs who agree to participate will receive a text message with their access code to the Internet intervention to access from their homes on a personal device. After online completion of baseline assessments, participants will be randomized to receive the intervention or general skin care information (control). Following the initial use, the participants may revisit the Internet intervention on a personal device or at the doctor's office on a tablet PC. Over the next 6 weeks, sun protection text reminders will be sent to intervention KTRs' cell phones and they will respond that they read the message. Control participants will receive text messages about general skin care.

Internet-based sun protection education

This study is being done to evaluate the effectiveness of a Sun Protection Strategies internet-based program for kidney transplant recipients. Since the medication taken to preserve the kidney transplant puts kidney transplant recipients at increased risk of developing a sunburn as well a skin cancer, the program will help people learn how to practice effective sun protection for their condition.

Cognitive interviews about an internet-based sun protection strategies program will be performed with up to 45 kidney transplant recipients (KTRs) who have participated in past surveys. A second group of 150 KTRs will be asked to evaluate the internet-based module for the effectiveness of information. A third group of 12 KTRs will be asked to evaluate the internet-based module for usability. A fourth group of 160 KTRs will be asked to take part in a randomized controlled trial evaluating the fully developed internet-based sun protection strategies program.

Kidney transplant recipients (KTRs) are at risk to develop skin cancer. Adequate sun protection after transplantation can reduce the risk of developing skin cancer. In 2006, the National Kidney Foundation (NKF) found that sun protection education delivery and content varied among transplantation centers. Clinicians rarely knew when to initiate education about skin cancer risks and prevention including timing and scope, and rarely demonstrated understanding of the importance of reminders for and repeated education of patients. (National Kidney Foundation 2006) The NKF supported standard, formal, well timed skin cancer prevention information and sending reminders to KTRs at the beginning of summer.

Aims:

1. To explore culturally sensitive use of terms describing ethnic cultural perceptions of sun burning, pigment darkening after sun exposure and description of skin color by the amount of photoprotective pigment in the skin.
2. To pilot test the internet-based sun protection brochure with English speaking KTRs representing 3 ethnic groups: White, Black and Hispanic.
3. To explore understanding of the importance of sun protection and the KTRs' confidence in their being able to practice sun protection.

Sun Protection of Kidney Transplant Recipients

Internet-Based Sun Protection Program for Kidney Transplantation Recipients

Use of sun protection will be measured using 10 questions about what a person regularly does in summer during a warm sunny day and during a cloudy day regarding: 1) use of sunscreen; 2) wearing hat; 3) shirt with sleeves; 4) sunglasses; and 5) staying in the shade. The scores for these questions will be summed to derive a dichotomous measure of sun protection use (1= use of sun protection often or always; 0 otherwise).

Three telephone interviews will be done on Mondays after at least 2 holiday weekends in which the weather is reported as sunny or partly sunny by the national weather service (Memorial Day, 4th of July and Labor Day) as well as one sunny non-holiday weekend. The KTR will be asked if they experienced a sunburn or skin irritation. The response will be dichotomous (yes/no).

Skin pigment as measured by reflectance spectrophotometry, ranging from limited \[225 area-under-the-curve (AUIC)\] to dense (75 AUIC).

Research Professor of Dermatology

Symptoms and General Pathology

Heart and Blood Diseases

Gland and Hormone Related Diseases

Wounds and Injuries

Neoplasm Metastasis

Myocardial Infarction

Infarction

Hyperparathyroidism

Hyperparathyroidism, Secondary

Fractures, Bone

Neoplastic Processes

Parathyroid Diseases

Endocrine System Diseases

iPTH at one year post transplantation below target range of iPTH by stage of CKD (KDOQI-guidelines).

iPTH at one year post transplantation within target range of iPTH by stage of CKD (KDOQI-guidelines).

iPTH at one year post transplantation above target range of iPTH by stage of CKD (KDOQI-guidelines).

Gunnar Sterner, MD A/Prof

Astrid Seeberger, PhD, A/Prof

Elin Isaksson, MD

The purpose of the study is to evaluate the long term vascular morbidity and mortality in kidney transplant recipients based on one year post transplant levels of intact parathyroid hormone.

Secondary hyperparathyroidism (SHPT) is a well known complication to chronic renal failure. With impaired renal function the phosphate excretion from the kidney is reduced. Together with low levels of 25- and 1,25-vitamin D3 and hypocalcemia this uremic mineral milieu drives the release of parathyroid hormone (PTH) and the development of SHPT. PTH has many functions but acts mainly to release calcium from the skeleton, to enhance calcium uptake from the intestines (by actions on vitamin D) and to lower serum phosphate by inducing phosphaturia. SHPT has been shown to cause vascular morbidity and fractures in the chronic kidney disease (CKD) patient. After successful renal transplantation (RT) the mineral disturbances are mostly recovered and stabilized at one year post RT, but in recent years it has been shown that SHPT persists in the major part of RT-recipients even after long term follow up. This has been associated with high risk of fractures and vascular related morbidity in the post transplant period. It has also been shown that low levels of iPTH in the post-transplant period might be associated with a high risk of fractures. Because of insufficient data on PTH levels and associated morbidity there is no specific recommendations of target PTH levels in the RT-patient. This indicates that there is need for further observational studies to describe the SHPT-associated morbidity in a post transplant cohort based on stabilized levels of post transplant iPTH.

Morbidity Related to Secondary Hyperparathyroidism After Renal Transplantation

Secondary Hyperparathyroidism Related Vascular and Bone Morbidity After Renal Transplantation - a 6 Year Follow up Retrospective Cohort Study.

Vascular events defined as (Myocardial infarction, Stroke, Peripheral Vascular Occlusion)

Start in Active Uremic Treatment (dialysis, renal transplantation)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of Sun Protection Education for Kidney Transplant Recipients	NCT01844713	Unspecified Com... Disorder Relate...	Workbook	18 Years - 85 Years	Northwestern University
Evaluation of Sun Protection Education for Kidney Transplant Recipients	NCT01844713	Unspecified Com... Disorder Relate...	Workbook	18 Years - 85 Years	Northwestern University
Study of Specific CD4 Tumors Th1 Responses in Renal Transplant After Occurrence of Cancer	NCT02843763	Disorder Relate... Cancer	Blood sample	18 Years - 80 Years	Centre Hospitalier Universitaire de Besancon
Study of Specific CD4 Tumors Th1 Responses in Renal Transplant After Occurrence of Cancer	NCT02843763	Disorder Relate... Cancer	Blood sample	18 Years - 80 Years	Centre Hospitalier Universitaire de Besancon
Sun Protection of Kidney Transplant Recipients	NCT01646099	Unspecified Com... Disorder Relate...	Internet-based ...	18 Years - 85 Years	Northwestern University
Morbidity Related to Secondary Hyperparathyroidism After Renal Transplantation	NCT01741064	Secondary Hyper... Disorder Relate...		18 Years - 85 Years	Skane University Hospital

Spots Global Cancer Trial Database for disorder related to renal transplantation