Skin and Connective Tissue Diseases

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Samples of normal breast tissue from organ donors for assessment of histology.

Gretchen Benson, Ph.D.

Breast cancer is the most common cancer among women in the United States. Breast cancer research has been hampered by the difficulty in collecting normal breast tissue. In this study, researchers will obtain samples of normal breast tissue from organ donors and will collect risk-factor data from next-of-kin.

The purpose of this study is to learn how normal breast develops and responds to stresses that are known to increase a woman s chance of developing breast cancer.

Following the breast-tissue donation from 20 volunteers, surgical technicians will make small incisions in the skin and tissue of the breast and remove several samples measuring about one-inch. Technicians also will take samples of the uterine lining to estimate the date of the last menstrual period. The tissue will then be sent to the National Cancer Institute for laboratory research studies. Steps will be taken to ensure that the identity of the participants remains confidential.

This pilot project, funded by a Breast Cancer Faculty Infrastructure Award, would determine the feasibility of obtaining samples of normal breast tissue from organ donors and collecting risk factor data from next-of-kin. The underlying goal of this initiative is to determine the associations between stages of breast development, risk factors for breast cancer, and gene expression. The study investigators are members of DCEG, CCR and the Transplant Resource Center of Maryland (TRC), a non-profit organization certified by HCFA and the state that processes most organ and tissue donations in Maryland. Trained staff or social workers employed by TRC who routinely obtain consent for donation from next-of-kin will also obtain consent for this study. The existing consent form for organ or tissue donation also includes informed consent for donation of tissue for research. Following organ procurement from 20 volunteers, trained surgical technicians employed by TRC who routinely assist intra-operatively, will sterilely remove tissue from each breast quadrant and split the samples; one portion will be embedded in OCT and snap frozen in liquid nitrogen and the other fixed in 10% buffered formalin. Samples of adipose tissue, blood, urine and endometrium (for menstrual dating) will also be obtained. MES in conjunction with SMH and BKV will assess the samples histopathologically and determine the quantity and quality of macromolecules (RNA, DNA, protein) contained within the tissues. Pending demonstration of the feasibility of this general approach, we will pursue additional funding for a larger study with optimized procedures. We have stopped recruiting patients.

Studying Normal Breast Tissue and Cancer Risk

Pilot Study to Collect Normal Breast Tissue From Organ and Tissue Donors

National Cancer Institute (NCI)

interventions of Cancéropôle Nord-Ouest during 1 year after an observational period of 2 years.

interventions of Cancéropôle Nord-Ouest during 2 years after an observational period of 1 year.

During the time defined by the randomization, the Cancéropôle Nord-Ouest offers to help to develop a clinical research activities in the centers. The various aids are : Structuring clinical research at the local level, Support (strategy, logistics, technical, Data management, methodology), a portfolio of "straightforward" studies ( French National Cancer Institute, cooperative groups conducting cancer clinical research, New Project), Good Clinical Practice training, Clinical research technician, Others,.....

interventions of the Cancéropôle Nord-Ouest

Jean-Claude BARBARE, MD

This study evaluates the interventions of the Cancéropôle Nord-Ouest in the development of clinical research in non-academic health institution. The randomization, in open label,determines the duration of the interventions. Half of participants will receive the interventions during 2 years, while the other half during 1 year.

French National recommendations ask to increase the accessibility of patients to clinical trials. But this accessibility is far from the optimal care in non-university healthcare institutions (public and private hospital). These non-academic healthcare facilities support at national level about 60% of chemotherapy and 70% of radiotherapy, but only 17% of the inclusions in trials.

A dissociation exist between a care package guaranteed on quality criteria (criteria to obtain the capacity to treat the cancers in healthcare institution) distributed all over the country, and the research, mainly concentrated in few referral centers (University hospital and French Comprehensive Cancer Centers).

Clinical trials allow patients to have early access to new treatments, optimal and formalized information, and supported by physicians in connection with a strict protocol for patients included.

Several studies have shown the existence of geographical and socio-economic determinants for access to reference centers and for the duration of survival of cancer patients. In France, it was found that for patients with gastrointestinal cancer, the remoteness of the place of residence compared to the nearest referral center and a higher level of deprivation decreased the probability of being supported in a reference center.

The hypothesis of the ERNU study is that aid from the Cancéropole Nord-Ouest facilitates clinical research activity resulting in a significant development of inclusions in non-university centers of the french north-west inter-region with an influence on the social and geographical inequalities recruitment.

Study Evaluating Intervention in the Development of Clinical Research in Non-Academic Health Institution (ERNU)

Randomized Trial Evaluating Intervention of the Cancéropôle Nord-Ouest in the Development of Clinical Research in Non-Academic Health Institutions (ERNU)

Measure the increase in inclusions in clinical trials of patients attending a Hospital or a private clinic "authorized to treat cancer" associated with a support provided by the Cancéropôle Nord-Ouest

assessment of the average of the reduction of social inequalities recruitment in clinical trial before and after the intervention of the Cancéropöle Nord-Ouest in each centers and in global. the social inequalities are calculated with the social and demographic tool developped by the french national institute of statistic and economic studies

Centre de traitement des données du Cancéropôle Nord-Ouest, Centre F. BACLESSE, Caen, France

Institut National de la Santé et de la Recherche Médical (INSERM) 1086 (Pr Guy LAUNOY) Centre F. BACLESSE, Caen, France

Centre Hospitalier Universitaire, Amiens

Florian Strasser, MD

Palliative Care procedures should be integrated early in the course of disease of patients with advanced incurable cancer. With this study, where the investigators follow adult patients with incurable cancer over 6 months or until death (whatever occurs earlier), the investigators aim to identify patients' needs for Palliative Care interventions (like support in illness understanding and decision making, symptom management, concrete end-of-life preparation, and others) and their remembered delivery by health care professionals. The investigators also collect data on patients care (use of chemotherapy, intensive care in the last month of life) and quality of death and dying (assessed by post-death-interviews with bereaved relatives). The aim is to have a "reality map" on current integration of oncology and palliative care and to test if appropriate Palliative Care interventions predict a better outcome.

Background The integration of Palliative Care (PC) in routine oncological care remains challenging, particularly in resource-restricted, culturally diverse, and regulatory/legal disperse settings like Romania. The investigators aim to collect original data ("reality map") about the implementation of Key-Interventions Palliative-Cancer-Care (KI-PCC) and specific outcome quality indicators (QI). The investigators also hypothesize that both predefined cofactors and appropriately delivered KI-PCC will predict quality of care.

Aim The aim is to detect gaps in the care of advanced incurable cancer patients. Because in this setting there are no predefined structures, the investigators focus on interventions perceived by the patient.

Methods The investigators' target population are advanced incurable cancer patients in different care settings (oncology clinics, Palliative Care centers, and hospice, varying in size, location (rural, urban) and grade of specialization) representing the heterogeneity of care in Romania. The investigators characterize the population using demographic data (EAPC basic dataset amended by country specific data like family structures and income), and validated tools for patient needs (IPOS, EQ5D). Need for and perceived Key interventions of Palliative Cancer Care (KI-PCC), measured by nurse-patient-interaction, are assessed. These KI-PCC include illness understanding, symptom management, decision making, spirituality, end-of-life-preparation, and network/family support. Further, the investigators collect defined outcome quality indicators (QI) for the integration (quality of death and dying, symptoms, aggressive end-of-life-care, inappropriate anticancer care, ER-visits). In addition, known, associated cofactors (e.g. comorbidities, living situation) are measured. The data collection will be longitudinal with monthly follow-ups for at most six months or until death. Focus groups at each participating center explore local influencing factors both for KI-PCC and QI. Several steps of quality assurance (source data verification, expert reviews of anticancer treatment, etc.) are introduced.

The analysis has three elements. First, the investigators will describe the population. Second, the investigators will map the patient perceived KI-PCC and defined outcome QI. Third, if data show robust after international expert review, the investigators will test the hypothesis that appropriate KI-PCC predict quality of care, measured by QI.

Expected impact The investigators expect that their approach will identify gaps in the integration of oncology and palliative care in their specific settings, focusing, however, mainly on patient and proxy view and backed by available information from outcome QI. The conduct of this protocol might also directly have an influence on patient care.

This approach will allow the development of tailored interventions in a next step. The investigators' approach may also serve as a model to measure the integration of oncology and palliative care in various settings, focusing on interventions.

Romanian-Swiss Research Programme IZERZO

Reality Map of Integrated Oncology and Palliative Care in Romanian and Swiss Cancer Centres

A composite endpoint, composed by the outcome indicators inappropriate anticancer care, repeated ER-admissions, high symptom burden (on IPOS), "aggressive" end-of-life-care, and bad quality of death and dying (QODD)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Studying Normal Breast Tissue and Cancer Risk	NCT00341692	Breast Neoplasm... Neoplasms by Si... Neoplasms Breast Diseases Skin Diseases		11 Years - 120 Years	National Institutes of Health Clinical Center (CC)
Study Evaluating Intervention in the Development of Clinical Research in Non-Academic Health Institution (ERNU)	NCT02765451	Clinical Resear... Cancer	interventions o...	-	Centre Hospitalier Universitaire, Amiens
Romanian-Swiss Research Programme IZERZO	NCT03237884	Advanced Incura...		18 Years -	Cantonal Hospital of St. Gallen

Spots Global Cancer Trial Database for development

Every month we try and update this database with for development cancer trials from around the world to help patients and their families find trials that might be right for them.
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Spots Global Cancer Trial Database for development

Every month we try and update this database with for development cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for development cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.