Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

All Conditions

Heart and Blood Diseases

Nervous System Diseases

Skin and Connective Tissue Diseases

Immune System Diseases

Diabetes Mellitus

Thrombosis

Embolism

Epilepsy

Migraine Disorders

Lupus Erythematosus, Systemic

Embolism and Thrombosis

Vascular Diseases

Connective Tissue Diseases

Autoimmune Diseases

Cohort includes women of reproductive age with diverse medical conditions (listed in inclusion criteria) who are referred to Family Planning felowship-trained physicians, seeking contraception counseling and administration.

Jody Steinauer, MD

Radhika Rible, MD MS

Tabetha Harken, MD MPH

Catherine Cansino, MD MPH

Sheila Mody, MD MPH

The investigators will conduct a prospective observational cohort study to investigate factors that influence contraceptive method utilization among women with medical conditions. The investigators will also investigate how women with medical conditions access to contraception and family planning fellowship trained specialist. After the baseline questionnaire, there be a 3 month and 6 month follow up questionnaire to investigate continuation and satisfaction with the contraceptive method. This study is unique because it will allow us to explore doing collaborative family planning research at the multiple UC medical campuses.

Many women with complex medical conditions who do not desire pregnancy do not receive contraception counseling from their primary or subspecialty care clinicians, and often they are not using contraception. This is an important deficiency as many have conditions that could worsen with pregnancy or for whom pregnancy can be complicated by the medical condition. Thus it is important for women with chronic disease to only become pregnant if they intend to do so. The United States Medical Eligibility Criteria for Contraceptive Use (USMEC), released in 2010, has greatly enhanced the ability of clinicians to counsel patient with complex medical conditions about their contraceptive options. It summarizes the safety of specific contraceptives when used on women with medical conditions. However, little is known about the contraceptive care of these women. We do not know if the availability of the USMEC has translated into evidence-based contraceptive counseling for these women. Further, little is known about their understanding of the interaction between their disease and pregnancy, their past experience and knowledge about contraception, and their contraceptive decision-making, satisfaction and continuation.

The purpose of the Complex Contraception Registry to is to recruit a cohort of women with complex medical conditions who are seen in contraception referral practices run by family planning fellowship trained physicians. We will assess their past experiences and baseline knowledge, their post-counseling experiences and choice of contraception, and their long-term satisfaction with and continuation of contraception. A multi-center registry is necessary because individual institutions see relatively few women with rare diseases such as a history of transplant surgery. The UC Family Planning Collaborative will facilitate recruitment of participants from the 5 UC medical campuses and will oversee their follow-up for one year.

Specific Aim include (1.) To investigate what factors influence contraceptive method utilization among women with complex medical conditions and their perceived risk of unintended pregnancy (2) To investigate how women with complex medical conditions access family planning fellowship trained specialist for contraception counseling and (3.) To assess satisfaction and continuation of contraceptive methods among women with complex medical conditions.

A Complex Contraception Registry

A Complex Contraception Registry - UC Family Planning Collaborative Study

Questionnaire is used to report continued use and satisfaction with multiple choice answer: very satisfied, somewhat satisfied, dissatisfied. Questionnaires will be administered at 3 months and 6 months after recruitment.

Measured with questionnaire at baseline, 3 months, and 6 months

Measured with questionnaire at 3 months and 6 months

University of California, Los Angeles

University of California, San Francisco

University of California, Irvine

University of California, Davis

University of California, San Diego

Assistant Professor

Neoplasms

Skin Diseases

Keratosis, Actinic

Keratosis

Precancerous Conditions

Central Nervous System Depressants

All Drugs and Chemicals

Antineoplastic Agents

Dermatologic Agents

Hematinics

Anesthetics

Fluorouracil

Aminolevulinic Acid

Liver Extracts

Methyl 5-aminolevulinate

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Patients who have undergone kidney or liver transplant within 2 years and have at least 4 premalignant skin lesions on the face, ears, scalp, forearms and/or dorsal hands. Patients will serve as their own control, and one side of the body will be randomized to either 5-FU plus PDT, and the other will receive PDT alone.

Patients with at least 4 actinic keratoses on the face, ears, scalp, forearms and/or dorsal hands. Patients will serve as their own control, and one side of the body will be randomized to either 5-FU plus PDT, and the other will receive PDT alone.

All patients will receive one cream, 5-Fluorouracil, and will be instructed to apply the cream according to the randomization schema to AKs on either the right or left side of the face/scalp once a day for 6 days prior to PDT. A baseline measurement of the tumor's ability to produce PpIX will be done by applying methyl-aminolevulinic acid (Metvixia® topical cream) to the selected AKs and using the Aurora© dosimeter. Prior to Metvixia, and again 3 hours after application, surface measurements of the PpIX fluorescence will be taken. Then, the two largest precancer lesions (one on the left side, one on the right side) will be biopsied under local anesthesia, followed by red light PDT (lasting \~8 minutes). The biopsy sites will be shielded from the light with a circular spot bandage.

5-Fluorouracil

Edward Maytin, MD, PhD

This randomized, intra-patient comparative study is designed to investigate the combination regimen of 5-fluorouracil cream (5FU) and Photodynamic Therapy (PDT), versus PDT alone, for its ability to generate significantly elevated levels of the target photosensitizer, protoporphyrin IX (PpIX), in lesions of actinic keratoses (AKs) and to more effectively treat and prevent recurrence of AKs. The target population comprises patients with solid organ transplants (renal, hepatic), as well as normal (immunocompetent) subjects to control for possible influences of immunosuppression.

This clinical trial will test a new combination of 5-fluorouracil cream (5FU) and methylaminolevulinate photodynamic therapy (MAL-PDT), versus MAL-PDT alone, as treatment for actinic keratoses (AKs) in immunosuppressed organ transplant recipients (OTRs) and an immunocompetent control group. Objectives: 1) Determine whether topical pretreatment with 5-FU selectively increases the amount of photosensitizer (PpIX) produced within AK lesions, relative to non-pretreated lesions. 2) Determine whether the combination treatment improves lesion resolution and reduces the incidence of new AKs. 3) Determine whether biomarkers in tissue and blood are predictive of patient responsiveness to 5FU (PpIX induction, new lesion incidence, and clinical toxicity).

We plan to enroll 20 organ transplant recipients and 20 normal patients, with AKs on face, scalp, ears, forearms or back of the hand through Dermatology and Transplant Clinic at Cleveland Clinic. Women of childbearing age must use contraception and have a negative pregnancy test.

Study participants will apply 5FU daily for 6 days; MAL/PDT is administered on 7th day. PpIX will be measured in lesions using a noninvasive dosimeter. Biopsies will be taken from selected lesions, and AKs will be photographed. Participants will be asked to complete a questionnaire to document adverse events. Patients are evaluated at day 14, and months 3, 6, 9, 12, to document AK clearance and new lesion appearance.

Combination Therapy With 5-Fluorouracil and Photodynamic Therapy in Post-transplant Premalignant Skin Disease

Combination Therapy With 5-Fluorouracil and Photodynamic Therapy for the Treatment of Post-transplant Premalignant Skin Disease

there is no plan to share individual participant data with other researchers.

The primary endpoint of this study will be the accumulation of PpIX at 3 h after MAL application (measured noninvasively, in each treated region).

(Region refers to the half-face or half-scalp area treated with PDT monotherapy, or the contralateral area treated with the 5-FU/PDT combination regimen).

Rate of AK clearance (Analyzed by linear mixed-effect model)

National Cancer Institute (NCI)

The Cleveland Clinic

Section Head, Molecular Dermatology; Chairman, Dermatology Research Committee

Patients who have undergone kidney or liver transplant within 2 years and have at least 4 premalignant skin lesions on the face, ears, scalp, forearms and/or dorsal hands.

Solid Organ Transplant With AKs

Patients with at least 4 actinic keratoses on the face, ears, scalp, forearms and/or dorsal hands.

Actinic Keratoses

Patients who underwent kidney or liver transplant within 2 years, and with at least 4 premalignant skin lesions on face, ears, scalp, forearms or dorsal hands. Patients will serve as their own control; one side of the body will be randomized to 5-FU plus PDT, and the other to PDT alone.

Total

Age, Categorical

Sex: Female, Male

Race (NIH/OMB)

Dr. Edward Maytin

Patient with solid organ transplant: half of body receiving combination therapy

Transplant With AKs; 5FU + PDT

Patient with solid organ transplant: half of body receiving PDT alone

Transplant With AKs; PDT Only

Patient without any organ transplant: half of body receiving combination therapy

Normals With AKs; 5FU + PDT

Patient without any organ transplant: half of body receiving PDT alone

Normals With AKs; PDT Only

Accumulation of Porphyrin (PpIX)

At 3 months post-PDT

At 6 months post-PDT

9 mos (see ClinCaRes2018))

12 mos (see ClinCaRes 2018)

Actinic Keratosis (AK) Clearance

The time (in months) following PDT treatment at which AK lesion counts first began to increase again. (Note: The nadir in AK lesion counts is reached at about 3 months in almost all patients).

Patients who did not receive 5-FU prior to PDT

PDT Only

Patients who received a week of topical 5-FU pretreatment prior to PDT

5-FU Followed by PDT

New AK Lesion Development

Patients who underwent kidney or liver transplant within 2 years, and with at least 4 premalignant skin lesions on face, ears, scalp, forearms or dorsal hands. Patients will serve as their own control; one side of the body will be randomized to 5-FU plus PDT, and the other to PDT alone.

All patients will receive one cream, 5-Fluorouracil (5FU), and will apply it to the AKs on either the right or left side of the face/scalp (per randomization scheme), once daily for 6 d prior to PDT. The ability of AKs to produce PpIX will be measured at baseline by applying methyl-aminolevulinate (Metvixia® topical cream) to the selected AKs using a fluorescence dosimeter. Prior to Metvixia, and again 3 hours after application, surface measurements of PpIX fluorescence will be taken. Then the two largest lesions (one on the left, one on the right) will be biopsied under local anesthesia, followed by red light PDT (lasting \~8 minutes). Biopsy sites will be shielded from light with a spot bandage.

Patients with at least 4 actinic keratoses on the face, ears, scalp, forearms and/or dorsal hands. Patients will serve as their own control, and one side of the body will be randomized to either 5-FU plus PDT, and the other will receive PDT alone.

All patients will receive one cream, 5-Fluorouracil (5FU), and will apply it to the AKs on either the right or left side of the face/scalp (per randomization scheme), once daily for 6 d prior to PDT. The ability of AKs to produce PpIX will be measured at baseline by applying methyl-aminolevulinate (Metvixia® topical cream) to the selected AKs using a fluorescence dosimeter. Prior to Metvixia, and again 3 hours after application, surface measurements of PpIX fluorescence will be taken. Then the two largest lesions (one on the left, one on the right) will be biopsied under local anesthesia, followed by red light PDT (lasting \~8 minutes). Biopsy sites will be shielded from light with a spot bandage.

Overall Study

Infections

Blood and Lymph Conditions

Symptoms and General Pathology

Rare Diseases

Hematologic Neoplasms

Communicable Diseases

Virus Diseases

Cytomegalovirus Infections

Herpesviridae Infections

DNA Virus Infections

Hematologic Diseases

Cytomegalic Inclusion Disease

Medical records of 250 allo-HSCT recipients will be evaluated retrospectively to determine the incidence and clinical outcomes of CMV viremia post HSCT, including both the direct (CMV disease) and indirect (such as invasive fungal infection, other viral infections, bacterial infection) effects on clinical outcomes.

120 recipients of allo-HSCT will be recruited into the prospective part of the study. Participants will be reviewed pre-transplant, 6, 12, 24 and 52 weeks following HSCT during routine clinical visits. clinical assessment will be made such as CMV viremia, transplant related complications and current medications.

Participants who are at high risk of CMV will have study blood sampling taken to assess immune functions

Blood sampling from prospective study participants will be taken for immune functions measurements

Blood sampling

Monica Slavin, MBBS FRACP

This study consists of two parts: 1) Part 1, a retrospective part on 250 consecutive patients following allogeneic haematopoietic stem cell transplant (allo-HSCT) at the Royal Melbourne Hospital from 2012 to 2017, inclusive, and 2) Part 2, a prospective part on 120 allo-HSCT patients from 4 sites in Australia: the Royal Melbourne Hospital, Peter MacCallum Cancer Centre, Austin Hospital, and Westmead Hospital.

In Part 1, medical records of allo-HSCT recipients will be evaluated to determine the incidence and clinical outcomes of CMV viremia post HSCT, including both the direct (CMV disease) and indirect (such as invasive fungal infection, other viral infections, bacterial infection) effects on clinical outcomes.

In Part 2, allo-HSCT participants at risk of CMV disease will be assessed to determine the association of host CMV-specific immunity with clinical management and outcomes over one year post allo-HSCT.

The overall aims of the study are to establish if CMV infection in allo-HSCT patients are associated with poor clinical outcomes; and whether measurement of immunological functions could provide an early indicator to identify patients at risk and appropriate timing for initiation of CMV treatment.

Cytomegalovirus (CMV) infection is recognised as one of the most common and important infectious complication of allogeneic haematopoietic stem cell transplantation (allo-HSCT). Despite the serious clinical implications of CMV reactivation, there is a paucity of data informing clinicians on how to best identify 'at risk' patients, timely commencement of management of the infection.

This study consists of two parts: 1) Part 1, a retrospective part, and 2) Part 2, a prospective part.

In Part 1, a retrospective cohort of 250 recipients of allo-HSCT at the Royal Melbourne Hospital will be reviewed. The study period will be between January 2012- December 2017, inclusive. The follow up period will be 6 months from the day of transplantation (ie. day 0 to 180). Data on patient demographics (age, sex, ethnicity), primary indication for transplantation, donor type (match, unmatched, minor mismatch, related or unrelated), graft source (stem cell, bone marrow, umbilical cord) conditioning regimen (myeloablative reduced intensity conditioning), graft versus host disease (GVHD) prophylaxis eg. T-cell depletion, days to neutrophil recovery, occurrence of acute and chronic GVHD and the therapy for GVHD (including steroid intensity, use of ATG etc.), associated bacterial and fungal infections, relapse and mortality, will be collected for analyses. CMV-negative patients will be used as control for economic comparisons.

In Part 2, 120 recipients of allo-HSCT will be recruited from 4 Australian hospitals (the Royal Melbourne Hospital, Austin Hospital, Peter MacCallum Cancer Centre, and Westmead Hospital). Participants will be reviewed pre-transplant, 6, 12, 24 and 52 weeks following HSCT during routine clinical visits. Clinical assessment will be made such as CMV viremia, transplant related complications and current medications. In addition, participants who are at high risk of CMV will have study bloods taken to assess immune functions with Quantiferon-CMV®, Quantiferon-Monitor® assay, CMV Elispot, peripheral blood mononuclear cells (PBMCs) and plasma for storage at time-points of 0, 6 and 12 weeks +/- 2 weeks after commencing anti-CMV treatment. The Quantiferon-Monitor® assay will be performed at the additional time points of 4, 18 and 26 weeks following HSCT.

The study consists of a retrospective and a prospective parts on patients developing CMV infection post allogeneic haematopoeitic stem cell transplant.

Cytomegalovirus (CMV) Reactivation in Allogeneic HSCT Recipient

Assessing the Impact and Complications of Cytomegalovirus (CMV) Reactivation in a Multi-site Study of Allogeneic Haematopoietic Stem Cell Transplant Recipient

The incidence and outcome of clinically relevant CMV viremia post HSCT will be assessed

Host CMV-specific T cell immunity status of 120 participants will be assessed prospectively against CMV related clinical outcomes to establish if correlations exist

Association of low level CMV viremia and the subsequent clinical outcomes

The economic cost attributable to managing CMV infection and CMV disease will be evaluated to provide a picture of health economics of the infection

CMV viral load will be assessed to determine an appropriate trigger to initiate treatment for CMV viremia

Association of low or inadequate global immune function (T-cell and TLR7 responses) will be correlated with an increased risk of developing CMV infection post HSCT

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Complex Contraception Registry	NCT02219269	Diabetes Cardiovascular ... Epilepsy Migraine Neurological Di... Cancer Bariatric Surge... Organ or Tissue... Lupus Erythemat... Other Hematolog... Other Venous Em...		18 Years - 45 Years	University of California, San Diego
Combination Therapy With 5-Fluorouracil and Photodynamic Therapy in Post-transplant Premalignant Skin Disease	NCT01525329	Actinic Keratos... Organ or Tissue...	5-Fluorouracil	18 Years -	The Cleveland Clinic
Combination Therapy With 5-Fluorouracil and Photodynamic Therapy in Post-transplant Premalignant Skin Disease	NCT01525329	Actinic Keratos... Organ or Tissue...	5-Fluorouracil	18 Years -	The Cleveland Clinic
A Complex Contraception Registry	NCT02219269	Diabetes Cardiovascular ... Epilepsy Migraine Neurological Di... Cancer Bariatric Surge... Organ or Tissue... Lupus Erythemat... Other Hematolog... Other Venous Em...		18 Years - 45 Years	University of California, San Diego
Cytomegalovirus (CMV) Reactivation in Allogeneic HSCT Recipient	NCT03806764	Cytomegalovirus... Haematological ... Organ or Tissue... Immune Suppress...	Blood sampling	18 Years -	Melbourne Health

Spots Global Cancer Trial Database for organ or tissue transplant; complications