Neoplasms

All Conditions

Rare Diseases

Neuroendocrine Tumors

Carcinoid Tumor

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Neuroendocrine Tumor

Gastro-enteropancreatic Neuroendocrine Tumor

Neuroepithelioma

Pharmaceutical Solutions

All Drugs and Chemicals

Antineoplastic Agents

Fluorodeoxyglucose F18

Olaparib

Somatostatin

Lutetium Lu 177 dotatate

Poly(ADP-ribose) Polymerase Inhibitors

Enzyme Inhibitors

Lu-177-DOTATATE and escalating doses of olaparib to determine the maximum-tolerated dose (MTD)

Lu-177-DOTATATE will be given by IV every 8 (+/-2) weeks for a total of 4 administrations

Lu-177-DOTATATE

Olaparib is given as a pill taken orally and is to be taken twice a day, starting from 2 days before the first administration of Lu-177-DOTATATE until 4 weeks after the last administration

Ga68-DOTATATE PET/CT scan will be done at baseline, at week 32, then every 24 weeks in followup period.

Ga dotatate scanning

F18-FDG PET/CT scan will be done at baseline, at week 32, then every 24 weeks in followup period.

FDG-PET scanning

Concomitant administration of an IV infusion of an amino acid (AA) solution will also be done for renal protection. The AA infusion will begin at least 30-60 minutes prior to injection of Lu-177-DOTATATE and will continue during and after the Lutathera infusion until the entire prescribed amount is infused.

Amino Acid infusion

Joy Zou, R.N.

Frank I Lin, M.D.

For more information at the NIH Clinical Center contact National Cancer Institute Referral Office

Background:

A neuroendocrine tumor is a rare type of tumor. It comes from body cells called neuroendocrine cells. Sometimes, these tumors develop in the gastrointestinal tract and pancreas. Researchers want to find out if a combination of drugs can shrink these tumors.

Objective:

To learn if people with certain neuroendocrine tumors can take a combination of 2 drugs, Lutathera and Olaparib, without having severe side effects, and if this treatment makes the tumors shrink.

Eligibility:

Adults 18 and older who have a neuroendocrine tumor in the pancreas or intestine that cannot be cured by surgery and has somatostatin receptors on the cells.

Design:

Participants will be screened under protocol 01-C-0129. They may have a tumor biopsy.

Eligible participants will get Lutathera through an intravenous (IV) infusion every 8 weeks for 4 cycles. One cycle is 8 weeks. Each cycle includes a follow-up visit at week 4. For the IV, a small plastic tube is put into an arm vein.

Participants will also take Olaparib by mouth twice a day for 4 weeks of each cycle. They will use a medicine diary to track the doses.

During the study, participants will have physical exams. They will have blood and urine tests. They will fill out questionnaires about their general well-being and function. Their heart function will be tested. They will have scans of their chest, abdomen, and pelvis. One type of scan will use an IV infusion of a radioactive tracer.

Participants will have a follow-up visit about 4 weeks after treatment ends. Then they will have follow-up visits every 12 weeks for 3 years. Then they will have yearly phone calls.

Background:

* Neuroendocrine tumors (NETs) of the gastrointestinal tract and pancreas are a rare and heterogeneous, but clinically important, group of neoplasms with unique tumor biology, natural history, and clinical management issues.
* While the treatment of localized NETs is surgical resection, a variety of therapeutic options are available for patients with advanced NETs. These include medical control of excess hormone levels and associated symptoms, cytoreductive surgery for patients with advanced disease, radioembolization, chemoembolization, systemic chemotherapy, interferon, longacting somatostatin analogs, receptor-targeted radionuclide therapy, and or liver transplantation.
* Somatostatin receptors (SSTR) have been shown to be overexpressed in a number of human tumors, including neuroblastoma, prostate cancer, pheochromocytomas, paragangliomas, and NETs, among many others.
* Lu-177-DOTATATE (Lutathera) is a SSTR-agonist agent which emits ionizing radiation that causes DNA damage to its target cells through both direct and indirect mechanisms. In addition, ionizing radiation has also been shown to induce cell death through what is known as the bystander effect, a phenomenon where cellular signaling from irradiated cells towards non-irradiated cells induces cellular damage and eventually death in nearby surrounding cells.
* Olaparib is a PARP inhibitor indicated as monotherapy in patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy. Olaparib has an established safety

profile and it is under investigation in several different cancers.

- The rationale behind using combination therapies in cancer stems from the potential of synergistic mechanisms of action of the involved agents. Olaparib is a PARP-inhibitor which blocks the repair of single-stranded DNA breaks and is especially effective when combined with other agents which induces DNA damage.

Objectives:

* Phase I:

  * Characterize the safety profile and tolerability of the olaparib + Lu-177-DOTATATE combination.
  * Determine the maximum tolerated dose (MTD) dose of the combination using the 3+3 dose escalation design.
* Phase II:

  * Measure the Best Overall Response Rate (BOR) by RECIST 1.1 at the MTD dose at completion of 4 cycles of treatment.

Eligibility:

* Clinical diagnosis of GEP-NET disease, histologically confirmed to be consistent with neuroendocrine tumor.
* Inoperable disease (metastatic, non-candidate for surgery with curative intent, locally advanced into vessels or other critical structures, etc.).
* Age \>=18 years.
* Must have presence of SSTR+ disease as documented by positive Ga-68-DOTATATE PET scan within 12 weeks prior to anticipated treatment.
* ECOG Performance Status \<= 1.

Design:

* Open-label, single-arm, single-center, phase I/II study evaluating the safety and efficacy of the Lu-177-DOTATATE + olaparib combination in patients with inoperable GEP-NET.
* For phase I, a standard 3+3 design will be used to determine MTD. It is estimated that approximately 15 to 24 patients will be required. Phase II will involve the use of a Simon optimal two-stage design to determine sample size and interim stopping rule.
* Assuming a combination of inevaluable patients or loss-to-follow-up of 10%, up to 24 patients will be accrued to phase I and 15 patients to phase II including the 6 phase I patients at MTD, with a total accrual ceiling of 42 patients to allow for a small number of inevaluable patients.

Lu-177-DOTATATE (Lutathera) in Combination With Olaparib in Inoperable Gastroenteropancreatico Neuroendocrine Tumors (GEP-NET)

Phase I/II Study of Lu-177-DOTATATE (Lutathera) in Combination With Olaparib in Inoperable Gastroenteropancreatico Neuroendocrine Tumors (GEP-NET)

.All IPD recorded in the medical record will be shared with intramural investigators upon request. In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.

Depending on what the speed of dose escalation and the final MTD dose, it is estimated that for 4 dose levels with up to 6 patients at each level, approximately 12 to 24 patients will be required for the phase I portion of the study. Standard 3+3 design will be used.

Proportion of patients who have a partial or complete response to therapy.

Kaplan-Meier curves of PFS and OS will be constructed. Median PFS and OS will be reported with 95% confidence intervals.

Preliminary information on the BOR will be presented as a percentage with 95% confidence intervals. Only evaluate patients will be included. Kaplan-Meier curves of PFS will be constructed. Median PFS will be reported with 95% confidence intervals.

National Cancer Institute (NCI)

Skin and Connective Tissue Diseases

Heart and Blood Diseases

Symptoms and General Pathology

Substance Related Disorders

Wounds and Injuries

Breast Neoplasms

Cardiotoxicity

Breast Diseases

Skin Diseases

Heart Diseases

Drug-Related Side Effects and Adverse Reactions

Chemically-Induced Disorders

Radiation Injuries

All women included in REBECCA cohort will be treated with helical tomotherapy for theur breast cancer.

Their cardiac follow-up will be based on echocardiography, CT coronary angiogram and blood samples

1. At baseline, before helical tomotherapy is performed, for each included woman will have:

   * measures of biomarkers of cardiac injury based on blood samples (including CRP, NT-Pro BNP, ..., microparticles and miRNA)
   * cardiologic examination including echocardiography for measurement of strain and strain rate
   * a CT coronary angiogram for measurement of coronary plaque indexes
2. Helical tomotherapy will be performed for all women included in the cohort.
3. At the end of tomotherapy, follow-up will include:

   * measures of biomarkers: at the end of radiotherapy, 6 months and 24 months after radiotherapy
   * cardiologic examinations including a echocardiography 6 and 24 months after radiotherapy
   * A CT coronary angiogram 24 months after radiotherapy

Helical tomotherapy for breast cancer

Carole Massabeau, MD

Marie-Odile Bernier, MD

Jean Ferrières, MD, PhD

Hervé Rousseau, MD, PhD

The purpose of this study is to determine whether a new technique of radiotherapy for breast cancer (helical tomotherapy) can induce cardiac toxicity that would be detected in the first two years after treatment. Screening of subclinical cardiac lesions with non-invasive cardiac imaging techniques combined with measures of circulating biomarkers of cardiac tissue lesions and coronary lesions would allow assessing radiation-induced cardiac toxicity at an early stage.

REBECCA study will consist in a monocentric prospective cohort that will include 120 women volunteers treated with adjuvant tomotherapy for breast cancer in the Institut Regaud Claudius-Toulouse (ICR) and followed for 2 years after radiotherapy.

In summary, women aged between 40 and 70 years, surgically treated at ICR for breast cancer and for whom adjuvant radiotherapy with tomotherapy is indicated, with no indication of chemotherapy will be eligible for the study.

REBECCA Study (RadiothErapy for BrEast Cancer and CArdiotoxicity)

REBECCA Study (RadiothErapy for BrEast Cancer and CArdiotoxicity): Evaluation of Radiation-induced Cardiotoxicity of Adjuvant Radiotherapy With Tomotherapy for Breast Cancer

The primary outcome is defined as a decrease of at least 5% in strain or strain rate measures based on cardiac ultrasound exam"2D strain" between the measurement before radiotherapy and measures 24 months after radiotherapy and / or an increase of at least 15% in the average index of coronary plaques measured with CT coronary angiogram between the measurement before radiotherapy and measures 24 months after radiotherapy .

Institut de Radioprotection et de Surete Nucleaire

Institut Claudius Regaud

University Hospital, Toulouse

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

Sophie JACOB

Gland and Hormone Related Diseases

Thyroid Neoplasms

Thyroid Diseases

Micronutrients

Anti-Infective Agents

Iodine

Cadexomer iodine

Fresh semen treated without irradiation before cryopreservation

cryopreserved semen without irradiation (n=60)

Pelvis scanning : acute irradiation (1 or 2 second) using low dose (n=30),

Bone scintigraphy : long irradiation (3h) using low dose (n=30),

Radioactive Iodine 131 therapy (RAT) applied for thyroid cancer : long irradiation (3h) using medium dose (n=60),

sperm will be frozen in Cryosperm® cryoprotectant medium (Origio). The samples will be packaged in previously identified high security straws (Cryobiosystem). Slow freezing of the straws will be carried out using the Nanodigicool® programmable device (Cryobiosystem).

Cryopreserved semen

sperm sample will be placed on the scanner's processing table to be exposed for 1 to 2 seconds. Several dose levels will then be made in order to limit the value of 17 mGy

Acute and low irradiation

sperm sample will be exposed to gamma radiation by adding a solution of Tc99m for 3 hours.

Long and low irradiation

sperm sample will be exposed to gamma radiation by adding a solution of I131 for 3 hours

Long and medium irradiation

Lise Laclautre, PharmD

Hanaé PONS-REJRAJI, PhD

Florence BRUGNON, MD, PhD

Solène VORILHON, MD, PhD

Cyril BOUCHE, PhD

Aurélie VEGA, PhD

Philippe VAGO, MD, PhD

Andreï TCHIRKOV, MD, PhD

Céline PEBREL-RICHARD, MD

Gaëlle SALAUN, MD, PhD

Lauren VERONESE, MD, PhD

Laetitia GOUAS, MD, PhD

Carole GOUMY, MD, PhD

Hanae PONS-REJRAJI, PhD

Differentiated thyroid cancer is the third cause of cancer in young men of childbearing age. Its treatment by irradiation with Radioactive Iodine 131 therapy (RAT) could alter spermatogenesis and result in azoospermia and permanent infertility. A preventive gametes cryopreservation was recommended before RAT, but without mentioning a period of teratogenic risk transmissible to the offspring. To date, RAT impact on human sperm nucleus is poorly known or even unknown, notably on telomere length.

Our objective is to define RAT effects on human sperm nucleus by in vitro irradiation exposure of human spermatozoa to mimicking that of the gonads in the context of irradiation with iodine131 used for thyroid cancer. We will analyze standard sperm parameters, major DNA alterations and telomere length using molecular and cellular assays. Nucleus morphology and chromatin organization will also be analyzed using 3D bio-imaging. This study will permit to optimize the indications for the preservation of fertility.

Our main objective is to measure the in vitro impact of irradiation treatment on sperm nuclear quality such as DNA fragmentation and oxidation, chromatin condensation and organisation, nucleus morphology and notably sperm telomere length (STL).

The secondary objectives are :

* to measure RAT impact on sperm parameters (vitality, motility and morphology)
* to measure the impact of cryopreservation on chromatin organisation and nucleus morphology
* to evaluate RAT impact on human sperm cells in comparison with cryopreservation
* to evaluate the impact of different doses and types of irradiation on human sperm cells
* to establish relations between potential alterations of standards sperm parameters (vitality, motility and morphology) and nuclear sperm parameters (DNA fragmentation and oxidation, chromatin condensation and organisation, nucleus morphology and STL.

Our final goal is to provide a significant improvement of men fertility diagnosis and optimize our fertility preservation practices.

To this end, we will expose ejaculated human spermatozoa (n = 90) at different (low and moderate) doses of gamma or X photons to mimic gonads irradiation. Absorbed doses by the samples were calculated using the GATE Monte Carlo platform (version 8.2). Experiment geometry settings were modelled as three dimension voxelized volumes inside the software by assigning a shape, size, distance and density for all the volumes created. All measurements will be made on surplus samples from men undergoing routine semen analysis at the Center for Reproductive Medicine, after receiving their written informed consent. Semen samples are collected and subdivided into 3 arms to analyse sperm quality after:

* irradiation exposure (3 conditions);
* a freezing- thawing cycle;
* fresh state: negative control without treatment.

Before (fresh state) and after each treatment we will analyse:

* standard semen parameters (vitality, motility and morphology) in accordance with WHO, 2010;
* STL using Flow FISH, q-PCR and q-FISH;
* chromatin condensation (chromomycin A3);
* DNA oxidization (8-OHdG residues);
* DNA fragmentation (TUNEL);
* 3D nucleus structure using 3D bio-imaging.

Impact of Ionizing Treatment on the Nuclear Structure of Human Spermatozoa.

To achieve this goal, we will expose human sperm to an irradiation dose of I131 to mimic the irradiation of gonads and sperm. Reliquat of semen will be cryopreserved (control condition). After thawing, the same sample will be subdivised into 2 groups in order to analyze the sperm quality :

* After an irradiation dose of I131
* After a cryopreservation

All measurements are made on surplus samples from men undergoing routine semen analysis at the Center for Reproductive Medicine, after receiving their written informed consent. Semen samples will be collected and subdivided into 3 arms to analyse sperm quality after:

* irradiation exposure (3 conditions);
* a freezing- thawing cycle;
* fresh state: negative control without treatment.

Before (fresh state) and after each treatment we will analyse:

* STL using Flow FISH, q-PCR and q-FISH;
* chromatin condensation (chromomycin A3);
* DNA oxidization (8-OHdG residues);
* DNA fragmentation (TUNEL);
* 3D nucleus structure using 3D bio-imaging.

All measurements are made on surplus samples from men undergoing routine semen analysis at the Center for Reproductive Medicine, after receiving their written informed consent. Semen samples will be collected and subdivided into 3 arms to analyse sperm quality after:

* irradiation exposure (3 conditions);
* a freezing- thawing cycle;
* fresh state: negative control without treatment.
* a freezing- thawing cycle;
* fresh state: negative control without treatment. Before (fresh state) and after each treatment we will analyse standard semen parameters (vitality, motility and morphology) in accordance with WHO, 2010;

We will compare effects induced by RAT and cryopreservation on each sperm sample. In order to limit the bias, for each irradiation treatment, a sample of sperm cells (cryopreserved control) will be treated under identical conditions.

All measurements are made on surplus samples from men undergoing routine semen analysis at the Center for Reproductive Medicine, after receiving their written informed consent. Semen samples will be collected and subdivided into 3 arms to analyse sperm quality after:

* irradiation exposure (3 conditions);
* a freezing- thawing cycle;
* fresh state: negative control without treatment.

Irradiation exposure will be realised under 3 conditions:

* acute and low irradiation : sperm sample will be placed on the scanner's processing table to be exposed for 1 to 2 seconds. Several dose levels will then be made in order to limit the value of 17 mGy.
* long and low irradiation: sperm sample will be exposed to gamma radiation by adding a solution of Tc99m for 3 hours.
* long and medium irradiation : sperm sample will be exposed to gamma radiation by adding a solution of I131 for 3 hours

We will correlate the effects induced by on vitality, motility and morphology and nuclear sperm parameters (DNA fragmentation and oxidation, chromatin condensation and organisation, nucleus morphology and STL.

Agence de La Biomédecine

University Hospital, Clermont-Ferrand

Blood and Lymph Conditions

Leukemia

Neoplasms, Radiation-Induced

Leukemia, Radiation-Induced

Hematologic Diseases

The study population is Korean radiation workers exposed to ionizing radiation in workplaces. Diagnostic medical radiation workers were not included in the study population.

Occupational radiation exposure

Health risks of radiation exposure in the moderate-to-high dose range have been well established. However, the risk remains unclear at low-dose ranges with protracted low-dose rate exposure, which is typical of occupational exposure. The purpose of this study is to construct a cohort of Korean radiation workers and to assess health effects associated with occupational radiation exposure. The study population is expected to be about 190,000 Korean radiation workers who have been registered with the Nuclear Safety and Security Commission since 1984. The national dose registry, the national cancer registry, the national vital statistics registry, and the national health insurance data are collected based on the Nuclear Safety Act. Through the linkage of those collected data, we will evaluate radiation-induced health risks including cancer and non-cancer diseases.

The study population of this study is approximately 190000 Korean radiation workers registered with the Nuclear Safety and Security Commission since 1984. Diagnostic medical radiation workers were not included in the study population. The national dose registry, the national cancer registry, the national vital statistics registry, and the national health insurance data for radiation workers are collected retrospectively or prospectively based on the Nuclear Safety Act. Through the linkage of those collected data, we will evaluate radiation-induced health risks including cancer and non-cancer diseases. This data collection will be continued at 5-year intervals to update information on existing study participants and recruit newly hired workers if possible.

Age- and sex-specific standardized incidence and mortality ratios will be calculated for overall comparisons of cancer and non-cancer disease risks with general population. For dose-response assessment, excess relative risk (per Gy) and excess absolute risk (per Gy) will be estimated with adjustments for age and potential confounders, such as lifestyle factors and socioeconomic status.

Epidemiological Study of Korean Radiation Workers

Health Effects Associated With Occupational Radiation Exposure Among Korean Radiation Workers (Korean Radiation Workers Study)

Cancer risk associated with occupational radiation exposure

Non-cancer disease risk associated with occupational radiation exposure

Korea Institute of Radiological & Medical Sciences

Radiologic technologists certified by the American Registry of Radiologic Technologists (ARRT) during 1923-1980 and residing in any U.S. state or territory.

Cari M Kitahara

Researchers at the National Cancer Institute and the University of Minnesota have followed a nationwide cohort of 146,022 radiologic technologists since 1982 (Boice 1992; Doody 1998; Mohan 2003; Sigurdson 2003). This is one of the largest cohorts of medical radiation workers studied to date (Yoshinaga 2003)and the only one with substantial numbers of women (73% female), extensive covariate data, both incident and death outcomes, and estimated occupational radiation doses. The overall study objectives are to: quantify radiation dose-response for cancers of the breast, thyroid, and other radiogenic sites; assess cancer risks associated with genotypic, phenotypic, or other biologically measurable factors; and determine if genetic variation modifies radiation-related cancer risks.

More than 110,000 technologists completed at least one of three comprehensive questionnaire surveys administered over the last 20 years and 18,500 are deceased. The First Survey was mailed during 1984-1989 to 132,454 known living radiologic technologists, of whom 90,305 (68%) completed the survey (Boice 1992). The Second Survey was mailed during 1993-1998 to 126,628 known living technologists, of whom 90,972 (72%) completed the questionnaire (Sigurdson2003). Both surveys included detailed questions about employment as a radiologic technologist, family history of cancer, reproductive history, height, weight, other cancer risk factors (such as alcohol and tobacco use), history of personal diagnostic and therapeutic medical radiation procedures, and information on cancer and other health outcomes. A third follow-up of this cohort was recently completed. During 2003-2005, the Third Survey was mailed or administered by telephone to 101,694 living cohort members who had completed at least one of the two previous surveys; 73,838 technologists (73%) completed the survey. This questionnaire elicited information on medical outcomes to assess radiation-related risks, detailed calendar-specific employment data to refine the occupational ionizing radiation dose estimates, and behavioral and residential histories for estimating lifetime ultraviolet (UV) radiation exposures.

The large number of women with estimates of cumulative radiation dose to specific organs (e.g. breast) (Simon 2006; see Figure 7 and Table 9) offers at are opportunity to study effects of low-dose radiation exposure on breast and thyroid cancers, the two most sensitive organ sites for radiation carcinogenesis in women.. We are not aware of any other study population in which both quantified radiation doses and biospecimens are available for individuals with protracted low-dose ionizing radiation exposures. Incorporation of assessment of the role of genetic polymorphisms and molecular variants in DNA repair and other genetic pathways that may be functionally important in radiation carcinogenesis would provide initial results on the possible role of genetic factors in the cancer-radiation relationship. Because large numbers of women are exposed to ubiquitous low-dose radiation from occupational, medical, and environmental sources, the presence of radiation-sensitive genetic variants that influence the risk of breast and other cancers would have important public health implications.

BACKGROUND:

The Radiation Epidemiology Branch and the University of Minnesota have followed a nationwide cohort of 146,022 U.S. radiologic technologists (USRT) since 1982 to assess cancer and other disease risks associated with long-term repeated low doses of ionizing radiation. The USRT Study is the largest cohort of medical radiation workers studied to date and the only one with substantial numbers of women, extensive covariate data, incident and fatal cancer and other outcomes, estimates of individual historical occupational radiation doses, personal medical radiation doses, and personal and residential solar ultraviolet radiation (UVR) doses, and biospecimens for breast and thyroid cancer cases and comparison subjects. This cohort is uniquely suited for addressing outstanding scientific questions about differences in risk related to the nature of radiation exposure, specifically whether risks are the same from a single or a few high-dose exposures (e.g. atomic bomb, radiotherapy) or from many small exposures over time that might be mitigated by DNA repair or other mechanisms. The nationwide distribution of the cohort, with wide-ranging UVR exposures, also offers a rare opportunity to evaluate risks for non-melanoma skin cancer with UVR, which will be a major focus of study during the next few years.

OBJECTIVES:

1. Assess risks of cancer and other diseases from long-term low-dose occupational and personal medical exposures.
2. Assess risks of cancer and other diseases from occupational exposure to emerging and evolving radiologic modalities (i.e. nuclear medicine, fluoroscopically-guided procedures).
3. Assess risks of skin and other cancers from solar ultraviolet radiation exposures.
4. Conduct discovery of genetic determinants for thyroid cancer and rapid replication of main genotype effects for breast cancer.
5. Evaluate gene-radiation and ionizing radiation-ultraviolet radiation interactions.

ELIGIBILITY:

All radiologic technologists certified by the American Registry of Radiologic Technologists for at least two years during 1926-1982 were eligible for study. Excluded were technologists who resided outside the U.S.

DESIGN:

Cohort study: The full USRT cohort consists of 146,022 radiologic technologists. The cohort is predominantly female (73%), Caucasian (93%), and presently 67 years old on average; 83% are living and 16% are deceased or presumed deceased. Three questionnaire surveys were conducted during 1983-2005 to collect information on occupational, personal medical, and personal and ambient residential ultraviolet radiation exposures, other cancer risk factors, and cancer and other disease outcomes. More than 110,000 technologists participated in the first and/or second surveys. The most recent follow-up (third survey) was conducted during 2003-2005 to obtain detailed work history information for improving occupational dosimetry. Enhanced estimates of individual annual badge dose (personal dose equivalent) and radiation absorbed doses to 12 organs and tissues (breast, thyroid, brain, red bone-marrow, lung, heart, ovary, colon, testes, skin of extremities, skin of head and neck, and lens of eye) were recently completed for survey participants. Linear dose-response analyses are underway to quantify risks from protracted low-dose radiation for cancers (e.g., breast, thyroid) and other radiation-related diseases (e.g., cardiovascular, cataracts). A fourth questionnaire survey is under development and will collect information on cancer and other disease outcomes, work history with nuclear medicine and fluoroscopically-guided procedures, and other risk factors. Fourth survey outcomes will be used to assess incident cancer risks with UVR exposure data collected on the third survey. Collection of blood or buccal cell samples from breast and thyroid cancer cases and comparison subjects continues. Future plans include a case-control study of basal cell carcinoma to assess risks with ultraviolet and ionizing radiation exposure, genetic variants, and interactions.

Cancer Risk in X-Ray Technologists: Second Survey

Cancer Risk in X-Ray Technologists

Occupational ionizing radiation-related risks for cancer and other medical outcomes.

Cancer and other disease risks associated with ultraviolet radiation exposure.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Lu-177-DOTATATE (Lutathera) in Combination With Olaparib in Inoperable Gastroenteropancreatico Neuroendocrine Tumors (GEP-NET)	NCT04086485	Gastroenteropan... Neuroendocrine ... Neuroendocrine ...	Lu-177-DOTATATE Olaparib Ga dotatate sca... FDG-PET scannin... Amino Acid infu...	18 Years -	National Institutes of Health Clinical Center (CC)
REBECCA Study (RadiothErapy for BrEast Cancer and CArdiotoxicity)	NCT02079272	Toxicity Due to... Breast Cancer Lesion; Cardiac	Helical tomothe...	40 Years - 70 Years	Institut de Radioprotection et de Surete Nucleaire
REBECCA Study (RadiothErapy for BrEast Cancer and CArdiotoxicity)	NCT02079272	Toxicity Due to... Breast Cancer Lesion; Cardiac	Helical tomothe...	40 Years - 70 Years	Institut de Radioprotection et de Surete Nucleaire
Impact of Ionizing Treatment on the Nuclear Structure of Human Spermatozoa.	NCT04715828	Sperm Preservat... Irradiated Seme...	Cryopreserved s... Acute and low i... Long and low ir... Long and medium...	18 Years - 45 Years	University Hospital, Clermont-Ferrand
Epidemiological Study of Korean Radiation Workers	NCT05380570	Occupational Ex... Neoplasms, Radi... Leukemia, Radia... Radiation Effec...	Occupational ra...	15 Years -	Korea Institute of Radiological & Medical Sciences
REBECCA Study (RadiothErapy for BrEast Cancer and CArdiotoxicity)	NCT02079272	Toxicity Due to... Breast Cancer Lesion; Cardiac	Helical tomothe...	40 Years - 70 Years	Institut de Radioprotection et de Surete Nucleaire
REBECCA Study (RadiothErapy for BrEast Cancer and CArdiotoxicity)	NCT02079272	Toxicity Due to... Breast Cancer Lesion; Cardiac	Helical tomothe...	40 Years - 70 Years	Institut de Radioprotection et de Surete Nucleaire
Cancer Risk in X-Ray Technologists: Second Survey	NCT00410475	Radiation-Induc... Breast+Neoplasm... Thyroid+Neoplas...		18 Years - 110 Years	National Institutes of Health Clinical Center (CC)
Impact of Ionizing Treatment on the Nuclear Structure of Human Spermatozoa.	NCT04715828	Sperm Preservat... Irradiated Seme...	Cryopreserved s... Acute and low i... Long and low ir... Long and medium...	18 Years - 45 Years	University Hospital, Clermont-Ferrand

Spots Global Cancer Trial Database for ionizing radiation