Nutritional and Metabolic Diseases

Symptoms and General Pathology

All Conditions

Neoplasms

Nervous System Diseases

Musculoskeletal Diseases

Behaviors and Mental Disorders

Rare Diseases

Obesity

Brain Neoplasms

Craniopharyngioma

Adamantinoma

Ameloblastoma

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Bone Neoplasms

Bone Diseases

Quality of Life

Brain Tumor, Childhood

Neuroepithelioma

Children and adolescents \>= 18 years of age new diagnosed with craniopharyngioma

* \>= 5 years of age and with incomplete resected tumor =\> randomized in two arms: immediate irradiation after surgery

incomplete resection, wait and watch, MRI-controls every 3 months, and irradiation at the time of progression of residual tumor

Immediate irradiation after incomplete resection (fractionated, percutaneous irradiation, 54 gy)

Radiation

wait ans watch, MRI controls, irradiation at the time of progression of residual tumor

wait and watch

Hermann L Müller, MD

The present investigation is a prospective, multicenter study evaluating craniopharyngioma patients' prognoses following the various currently-practiced therapeutic strategies.Primary goals of the study are to establish quality standards and compare the various therapy strategies with respect to their effectiveness and impact on the quality of life of treated patients. A stratified randomization of two treatment arms will be conducted with respect to timing of postoperative irradiation for the subgroup of patients ≥5 years of age whose tumors are incompletely resected. The researchers will investigate whether an immediate, postoperative irradiation is superior to progression-contingent irradiation based on alterations to quality of life (PEDQOL) from the time randomization is initiated (3rd month post op) to 3 years after randomization. Progression-free survival and overall survival will be examined as closely-related subgoals.Postoperative data will be evaluated via a surveillance study for all complete resection patients as well as for those patients under 5 years of age regardless of their resection grade.

Prospective Study of Children and Adolescents With Craniopharyngioma

KRANIOPHARYNGEOM 2007 - Multicenter Prospective Study of Children and Adolescents With Craniopharyngioma

•Randomized investigation of children (≥ 5 years of age) and adolescent QoL changes (main goal assessment) following incomplete craniopharyngioma resections at primary diagnosis per QoL endpoint scores (PEDQOL "physical functions" domain) measured from 3rd month after surgery for 3 years after randomization; and the progression-free and total survival rates (subgoal assessments) relative to how these rates relate to postoperative irradiation timing (immediate postsurgery irradiation versus wait-and-see approach + progression-contingent irradiation of residual tumor).

* Compilation of applied therapy strategies for craniopharyngiomas in children and adolescents using data capture conforming to SIOP brain tumor groups
* Evaluation of patients' remission status following the various therapy strategies/modalities for craniopharyngiomas using data detection consistent with SIOP brain tumor groups
* Evaluation of the health status (ophthalmologic, neuropsychologic and endocrine conditions) and health-related QoL of children and adolescents following treatment of craniopharyngiomas using data capture conforming to SIOP brain tumor groups

German Society for Pediatric Oncology and Hematology GPOH gGmbH

Arbeitsgemeinschaft Pädiatrische Endokrinologie (APE)

Deutsche Gesellschaft für Endokrinologie (DGE)

Arbeitsgemeinschaft Pädiatrische Radioonkologie (APRO)

Deutsche Gesellschafr für Radioonkologie (DEGRO)

Deutsche Kinderkrebsstiftung

International Society of Paediatric Oncology

Klinikum Oldenburg gGmbH

Professor MD

Inflammation

Anorexia

Wasting Syndrome

Cachexia

Signs and Symptoms, Digestive

Body Weight

Weight Loss

Body Weight Changes

Thinness

Anti-Obesity Agents

All Drugs and Chemicals

Appetite Depressants

Nine lung cancer patients were diagnosed as anorexic based on the results obtained by the appetite assessment tools we used. These patients were studied by fMRI regarding the hypothalamic activity.

Four lung cancer patients were diagnosed as non-anorexic based on the results obtained by the appetite assessment tools we used. These patients were studied by fMRI regarding the hypothalamic activity.

Two healthy volunteers with normal appetite were studied by fMRI regarding the hypothalamic activity.

Alessandro Laviano, MD

The pathogenesis of cancer anorexia is complex and multifactorial. However, a number of consistent and robust evidence point to a prominent role for the central nervous system. In particular, the hyperactivation of the immune system, due to tumour growth, causes a systemic inflammatory response primarily mediated by pro-inflammatory cytokines. At the central level, inflammatory response profoundly alters the activity of the hypothalamic nuclei, which are involved in the regulation of energy homeostasis. In particular, pro-inflammatory cytokines inhibit prophagic neurons activity, while enhance the activation of the anorexigenic neurons. Although supported by compelling experimental evidence, it should be acknowledged that this pathogenic hypothesis has not been confirmed yet by human studies.

Aim of the present study is to determine the specific pattern(s) of the brain activation after assumption of a standard meal in both anorexic and non-anorexic cancer patients to reveal potential differences, which will be correlated with the levels of concurrently measured circulating pro-inflammatory cytokines. The results obtained would help in assessing the role of the central nervous system and, in particular of the hypothalamus, in the pathogenesis of cancer anorexia.

After approval of the study protocol by the Ethical Committee of our Institution (Azienda Policlinico Umberto I, Sapienza University, Rome, Italy), 9 anorexic cancer patients, 4 non-anorexic cancer patients and 2 healthy individuals will be studied. The sample size is based on studies of neuroimaging already published and available on international journals.

Patients with confirmed cancer diagnosis will be enrolled before the initiation of any anti-cancer treatments. The presence/absence of anorexia will be investigated using a specific questionnaire (Cangiano et al., 1990) and a visual analogue scale (VAS). After an overnight fasting, blood samples will be collected from cancer patients and control subjects and interleukin(IL)-1, IL-6 and Tumor Necrosis Factor-α (TNF-α) levels will be measured by a commercially available ELISA kit.

On the same day, hypothalamic activation pattern(s) will be evaluated in patients and in control subjects by fMRI. After basal evaluation, all the groups will receive a standard oral meal, i.e., a 200 mL hypercaloric oral nutritional supplement providing 300 Kcal, and then a second fMRI scan will be performed. Using a computerized software, the average value of the grey for the hypothalamus will be calculated, and normalized for the one obtained in the basal condition, to obtain the percentage (%) of activation (or inhibition) of the hypothalamus.

Data obtained will be statistically analyzed using the t-Student and Bonferroni tests.

Cancer Anorexia and the Central Nervous System

Neuroimaging of Hypothalamic Activity During Cancer Anorexia

We observed different BOLD signal in the region of the hypothalamus between the 3 groups. The BOLD signal and the activation/no activation areas were statistically analyzed by a specific statistical method (i.e., parametric mapping).

University of Roma La Sapienza

MD, Associate Professor

Nine patients were studied by fMRI before and after administration of a standard meal. The presence of serious adverse events (i.e., allergy, claustrophobia) were investigated. The presence of nausea and vomiting after the intake of the standard meal was also investigated.

ANOREXIC CANCER PATIENTS

Four patients were studied by fMRI before and after administration of a standard meal. The presence of serious adverse events (i.e., allergy, claustrophobia) were investigated. The presence of nausea and vomiting after the intake of the standard meal was also investigated.

NON-ANOREXIC CANCER PATIENTS

Two volunteers were studied by fMRI before and after administration of a standard meal. The presence of serious adverse events (i.e., allergy, claustrophobia) were investigated. The presence of nausea and vomiting after the intake of the standard meal was also investigated.

CONTROL GROUP

Based on the anorexia instruments that we used, we considered these patients as anorexic.

Based on the anorexia instruments that we used, we considered these patients as non-anorexic

These were healthy subjects. 1 MD working at the Oncology Dept. , 1 family member of one of the patients enrolled.

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Italy

Region of Enrollment

PROF. ALESSANDRO LAVIANO

Patients revealed as anorexic were studied regarding BOLD signal activity by fMRI

Patients revealed as non-anorexic were studied regarding BOLD signal activity by fMRI

Healthy subjects were studied regarding BOLD signal activity by fMRI

ACTIVATION/NON ACTIVATION OF SPECIFIC BRAIN AREAS, EVALUATED BY FUNCTIONAL MAGNETIC RESONANCE

We evaluated 9 patients with lung cancer who met the inclusion criteria and were enrolled in the study. According to the protocol, the presence of anorexia was assessed by appetite assessment tools.

According to the protocol, we evaluated 4 patients with lung cancer who met the inclusion criteria and were enrolled in the study. According to the protocol, the absence of anorexia was assessed by appetite assessment tools.

Two healthy volunteers were evaluated and included in the study as controls. Their appetite was normal, as assessed by appetite measurement tools.

Overall Study

Blood and Lymph Conditions

Immune System Diseases

Gland and Hormone Related Diseases

Lymphoma, Large B-Cell, Diffuse

Lymphoma

Lymphoma, B-Cell

Hypogonadism

Gonadal Disorders

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Endocrine System Diseases

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Lymphosarcoma

Oculocerebral Syndrome With Hypopigmentation

Antineoplastic Agents

Doxorubicin

Liposomal doxorubicin

Testosterone

This study is an observational cross-sectional study which aims to investigate the relationship between treatment with chemotherapy and the development of low levels of testosterone in the blood in patients cured for aggressive lymphoma. We hypothesize that patients in turn will develop sexual dysfunction and poor quality of life because of this reduced level of testosterone. Cancer treatment is increasingly effective and the overall survival higher, which makes issues like sexuality and long-term quality of life more and more important to address in cured cancer patients. Patient sexuality and quality of life is measured by 3 questionnaires filled out once, and serum testosterone by a single blood sample. If serum testosterone is in the lower part of the normal reference interval, patients will be offered further hormonal evaluation by department of growth and reproduction at Copenhagen University Hospital. We hope to show that future follow up visits should include focus on sexuality and serum testosterone. Questionnaires and blood samples can be implemented easily and without great cost.

Diffuse large B-cell lymphoma and Hodgkin Lymphoma are two aggressive lymphomas often treated with doxorubicin containing chemotherapy. Doxorubicin is an anthracycline and is known to be toxic to both Leydig Cells of the testes and hormone-producing cells of the hypothalamus. Therefore patients treated with this drug are at risk of developing hypogonadism. Standard follow-up programs do not include investigation of hormone levels. With this study we aim to investigate the extent of hypogonadisme in patients treated with anthracycline containing chemotherapy, to clarify whether it is relevant to include serum testosterone in standard follow-up programs.

Our Hypothesis:

Hypothesis 1: A significant proportion of long-term male survivors of HL and DLBCL have impaired QoL due to sexual dysfunction.

Hypothesis 2: A significant proportion of long-term male survivors of HL and DLBCL have reduced levels of testosterone.

Hypothesis 3: A significant relationship between QoL, sexual dysfunction and testosterone levels exists.

To clarify the extent of hypogonadisme a single blood test including s-total-testosterone will be drawn once, and levels below age adjusted reference levels will be classified as hypogonadisme. To assess patients sexuality and quality of life, 3 questionnaires will be filled out; the EORTC QLQ-C30 for general quality of life, EORTC SHQ-22 for sexual health and IIEF-5 for sexual function.

To evaluate whether normal reference levels are sufficient in the examination of lymphoma survivors, included men with serum testosterone in the lower part of the normal reference interval will be offered further hormonal evaluation at the department of growth and reproduction at Copenhagen University hospital. Blood test results will be evaluted by this research group.

Gonadal Dysfunction in Male Long-term Survivors of Malignant Lymphoma; Vitality-Obs

Vitality-Obs; An Observational and Descriptive Cross-sectional Study of Gonadal Dysfunction in Male Long-term Survivors of Malignant Lymphoma

The frequency of sexual dysfunction measured by serum-testosterone level below age adjusted reference levels, in patients with DLBCL or HL.

According to SHQ-22 symptom scores. High symptoms scores represents high level of symptoms.

According to SHQ-22 function scores. High symptoms scores represents high level of functioning.

According to QLQ-C30 function scores. High function scores represents a high level of functioning.

According to QLQ-C30 symptoms scores. High symptoms scores represents high level of symptoms.

According to QLQ-C30 global health scores. High symptoms scores represents high level of global health.

The frequency of serum SHBG levels above the reference level

The frequency of serum LH levels above the reference level

The frequency of serum Inhibin B levels below the reference level

The frequency of serum FSH levels above the reference level

The frequency of serum estradiol levels above the reference level

The frequency of serum estradiol levels below the reference level

The frequency of serum hemoglobin levels above the reference level

The frequency of serum hematocrit levels above the reference level

The frequency of serum free testosterone levels above the reference level

Lars Møller Pedersen

Senior Consultant

Adenoma

Pituitary Diseases

Pituitary Neoplasms

Neoplasms, Glandular and Epithelial

Hypothalamic Diseases

Brain Diseases

Central Nervous System Diseases

Endocrine Gland Neoplasms

Hypothalamic Neoplasms

Supratentorial Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

the tumor abuting or displacing the hypothalamus in the preoperative MR images

hypothalamic involvement (the hypothalamus is no longer identifiable) in the preoperative MR images

Total resection of HIPA in a single surgery

Total resection

HIPA was resected subtotally at first time, and the tumor remnant was removed at a later date

Staged resection

HIPA was resected subtotally at first time, and the tumor remnant was controled by the stereotactic radiation therapy

Subtotal resection followed by stereotactic radiation therapy

Tao Huang, PhD, MD

Prospective and randomized evaluate efficiency and safety of different treatment strategies for hypothalamus-invading pituitary adenomas (HIPA)

There are various treatment strategies for hypothalamus-invading pituitary adenomas (HIPA), such as total resection (TR), subtotal resection with radiosurgery (STR+RS), etc. However,the optimal treatment of HIPA is still controversial. In this study, we want to evaluate the efficiency and safety of different treatment strategies in adults with HIPA.

Efficiency and Safety of Different Treatment Strategies in Adults With Pituitary Adenomas With Hypothalamic Involvement

EQ-5D will be evaluated before the first surgery and after the first surgery in 2 years

EQ-5D will be evaluated before the second intervention and after the second intervention in 3 months

Visual Acuity statue will be evaluated using Snellen's chart before the first surgery and after the first surgery in 2 years

Visual Field statue will be evaluated using a Humphrey visual field analyser before the first surgery and after the first surgery in 2 years

Whether the Hormone Replacement Therapy was used (Yes or No) before the first surgery and after the first surgery in 2 years

Volumetric analysis of tumor volume before the first surgery, intraoperatively and 3 months and 2 years after the first surgery will be performed. In addition, Tumor volume will be evaluated before the second intervention and intraoperatively. Gross total resection is defined as no tumor present in gadolinium enhanced T1 sequences.

Wuhan Union Hospital, China

Diseases and Abnormalities at or Before Birth

Cysts

Meningioma

Arachnoid Cysts

Neoplasms, Vascular Tissue

Meningeal Neoplasms

Central Nervous System Cysts

Congenital Abnormalities

Nervous System Malformations

Lipogranulomatosis

Hermann L Mueller, MD

Svenja Boekhoff

KRANIOPHARYNGEOM Registry 2019 will prospectively collect and descriptively analyse data on diagnostics, treatment, and follow-up of patients with craniopharyngioma. In continuation of preceding studies also patients with xanthogranuloma, meningioma, pituitary adenoma, prolactinoma and cystic intracranial malformations will be registered.

Multicenter Registry for Patients With Childhood.Onset Craniopharyngioma, Xanthogranuloma, Cysts of Rathke's Pouch, Meningioma, Pituitary Adenoma, Arachnoid Cysts

KRANIOPHARYNGEOM Registry 2019 Multicenter Registry for Patients With Childhood-onset Craniopharyngioma, Xanthogranuloma, Cysts of Rathke's Pouch, Meningioma, Pituitary Adenoma, Arachnoid Cysts

Overall survival as measured by Kaplan Meyer analyses

Progression-free survival as measured by Kaplan Meyer analyses

Domains of the PedQol instrument (questionnaire for assessment of health-related QoL in childhood cancer patients.

Deutsche Gesellschaft für Kinderendokrinologie und Diabetologie (DGKED)

Deutschen Gesellschaft für Radioonkologie (DEGRO)

Neoplasm Metastasis

Hyperinsulinism

Overweight

Overnutrition

Nutrition Disorders

Antihypertensive Agents

Vasodilator Agents

Diazoxide

DIAZOXIDE

Raja BRAUNER, MD,PhD

In children treated for intracranial lesions, the 2 factors of the obesity are : the location of the lesion (hypothalamic-pituitary region) and craniopharyngiomas

Approximately 80 % of the hypothalamic-pituitary lesions that occur in children are craniopharyngiomas with one or three cases per 1 million children each year.

One major problem remains unsolved : the obesity

This study is performed to optimize the management of the children with hypothalamic-pituitary lesions by reducing the hyperinsulinemia due to the lesion and the surgery

Effect of Diazoxide on the Obesity Secondary to Hypothalamic-pituitary Lesions

Clinical Assessment of the Treatment With Diazoxide in Children Suffering From Obesity and Hyperinsulinemia Secondary to Surgery of Hypothalamic-pituitary Lesions

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Prospective Study of Children and Adolescents With Craniopharyngioma	NCT01272622	Craniopharyngio... Obesity	Radiation wait and watch	1 Day - 18 Years	Klinikum Oldenburg gGmbH
Cancer Anorexia and the Central Nervous System	NCT01564693	Cancer Cachexia		18 Years - 85 Years	University of Roma La Sapienza
Gonadal Dysfunction in Male Long-term Survivors of Malignant Lymphoma; Vitality-Obs	NCT04630275	Hypogonadism		18 Years - 65 Years	Herlev Hospital
Efficiency and Safety of Different Treatment Strategies in Adults With Pituitary Adenomas With Hypothalamic Involvement	NCT04863456	Pituitary Adeno...	Total resection Staged resectio... Subtotal resect...	18 Years -	Wuhan Union Hospital, China
Prospective Study of Children and Adolescents With Craniopharyngioma	NCT01272622	Craniopharyngio... Obesity	Radiation wait and watch	1 Day - 18 Years	Klinikum Oldenburg gGmbH
Multicenter Registry for Patients With Childhood.Onset Craniopharyngioma, Xanthogranuloma, Cysts of Rathke's Pouch, Meningioma, Pituitary Adenoma, Arachnoid Cysts	NCT04158284	Craniopharyngio... Obesity		1 Day - 18 Years	Klinikum Oldenburg gGmbH
Effect of Diazoxide on the Obesity Secondary to Hypothalamic-pituitary Lesions	NCT00306683	Hypothalamic-pi... Craniopharyngio...	DIAZOXIDE	6 Years - 18 Years	Assistance Publique - Hôpitaux de Paris
Gonadal Dysfunction in Male Long-term Survivors of Malignant Lymphoma; Vitality-Obs	NCT04630275	Hypogonadism		18 Years - 65 Years	Herlev Hospital
Gonadal Dysfunction in Male Long-term Survivors of Malignant Lymphoma; Vitality-Obs	NCT04630275	Hypogonadism		18 Years - 65 Years	Herlev Hospital
Multicenter Registry for Patients With Childhood.Onset Craniopharyngioma, Xanthogranuloma, Cysts of Rathke's Pouch, Meningioma, Pituitary Adenoma, Arachnoid Cysts	NCT04158284	Craniopharyngio... Obesity		1 Day - 18 Years	Klinikum Oldenburg gGmbH

Spots Global Cancer Trial Database for hypothalamus

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