Neoplasms

Digestive System Diseases

All Conditions

Skin and Connective Tissue Diseases

Blood and Lymph Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Esophageal Neoplasms

Skin Neoplasms

Stomach Neoplasms

Head and Neck Neoplasms

Hematologic Neoplasms

Breast Neoplasms

Lung Neoplasms

Urinary Bladder Neoplasms

Kidney Neoplasms

Uterine Neoplasms

Hematologic Diseases

Breast Diseases

Skin Diseases

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Stomach Diseases

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Kidney Diseases

Genital Neoplasms, Female

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Esophageal Cancer

Stomach Cancer

Genomic profiling, indicated as assessed by the medical need and as deemed appropriate by the physician according to routine practice

Genomic testing

Richard Greil, MD

Thomas Winder, MD

Armin Gerger, MD

Andreas Seeber, MD

Martin Pecherstorfer, MD

Andreas Petzer, MD

Petra Pichler, MD

Klaus Wilthoner, MD

Sonja Heibl, MD

Christian Singer, MD

Edward Wöll, MD

There is no evidence available about which molecular profiling methods are currently used for cancer patients in Austrian clinical practice. The construction of the registry proposed as a completely independent research endeavor, will be helpful for scientific evaluation and the establishment of highly credible data.

In the situation of enormous possible beneficial options for patients, health care systems, researchers and companies and the simultaneously present high number of uncertainties, the establishment of an independent registry for patients undergoing any type of comprehensive genomic profiling offers many advantages.

In particular, an overview of the speed of development, the "market penetration", the use of the technology in specific indications (tumor types, stages and in specific situations of unresponsiveness to certain drugs), the frequency by which treatment decisions will definitely follow the result of comprehensive genomic profiling and the reasons for this, the treatment outcome of such patients, the platform technologies applied (in-house (which types), vs. commercial) and the development of these parameters over time and in relation to the development of novel drugs will be analyzed.

The registry proposes to cover the time period from the years 2016 to 2019, which will allow for assessment of both the current and emerging landscape of genomic/molecular testing practice in Austria and effect of molecular profiling on patient care and outcome.

Genomic Testing and Resulting Medical Decisions

The Use of Genomic Testing and the Resulting Medical Decisions According to Target Identification

To describe types of:molecular profiling methods used in the Austrian registry centres

To describe types of cancer, for which comprehensive molecular profiling is used

To describe the timing of molecular profiling in relation to stage of the disease (e.g. at diagnosis, after surgery, radiation therapy, after first/second/third/late line)

To describe targets identified:

* number of patients with at least one mutation identified
* number of patients with at least one druggable target identified
* number of patients with more than one druggable targets identified
* number of druggable targets per cancer type

To describe tests used and quality standards:

* to compare results of NGS based molecular test systems with single marker tests or small gene panel tests
* quality standards of the test methods used (TAT, certification status)
* to evaluate development of methods used over time
* usage of commercial testing vs. in-house testing, platforms used, and number of genes as well as gene size analyzed (eg whole exome with or without selected intron sequencing vs. hot spot exome sequencing)

To describe treatment decisions:

* frequency by which treatment decision follows the result of NGS testing
* frequency with druggable targets with available on-label therapy option
* treatment decisions in the presence of more than one druggable target

To describe outcome of treatment in patients receiving therapy in concordance with the test result

Roche Pharma AG

AstraZeneca

Arbeitsgemeinschaft medikamentoese Tumortherapie

Patients in this arm will receive conventional radiation with or without chemotherapy

Patients in this arm will receive Tomotherapy based IGRT with or without chemotherapy

Standard Pelvic Radiation 50 Gy/ 25 fractions over 5 weeks

Conventional Radiation

Patients in this arm will received Tomotherapy based Image Guided Intensity Modulated Radiotherapy to a dose of 50 Gy/25 fractions/5 weeks

Tomotherapy based IGRT

Supriya Chopra, MD,DNB

The study tests Tomtherapy based Image Guided Radiation against conventional radiation techniques for it's ability to reduce long term small bowel toxicity.

Postoperative pelvic radiotherapy (+/- chemotherapy) leads to reduction in the risk of local recurrence and improves progression free survival (PFS) in patients with post-operative intermediate and high risk factors following Wertheim's hysterectomy. However, adjuvant external beam radiotherapy and vaginal cuff brachytherapy increase the risk of small bowel toxicity such that patients undergoing external beam pelvic radiotherapy and vaginal cuff brachytherapy may have 15-18% incidence of late RTOG ≥ grade II small bowel toxicity. Phase II studies using new techniques like Intensity Modulated Radiotherapy (IMRT) have reported up to 50% reduction in small bowel doses with up to 30% reduction in ≥ grade II acute toxicity. However, there is no randomized data demonstrating the benefit of highly specific and conformal techniques like image guided (IG)-IMRT in reducing radiation induced small bowel toxicity in patients with cervical cancers. The present study is being proposed to test if use of IG-IMRT with Tomotherapy is associated with reduced small bowel late toxicity

Patients enrolled are randomized to either conventional arm or tomotherapy arm for treatment after stratification according to type of surgery the patient underwent and the indication of chemotherapy along with radiation

Tomotherapy vs Conventional Radiation for Adjuvant Pelvic RT in Ca Cervix

Phase III Randomized Trial of Image Guided Intensity Modulated Radiotherapy (IG-IMRT) and Conventional Radiotherapy for Late Toxicity Reduction After Postoperative Radiotherapy in Ca Cervix.

Time to event and severity of late bowel toxicity are assessed

Data on dosimetric analysis of small bowel dose in reference to volume are collected in both arms and assessed for predicting dose prescription for ≥ grade II late bowel toxcity

Acute toxicity will be reported using CTCAE V.3.0. CTCAE forms will be filled before starting radiation, weekly during radiation treatment and on each scheduled follow-up. If any toxicity occurs at another time point additional forms will be filled to capture the same. Acute toxicity difference will be calculated between the two study arms.

Images acquired pre-operatively are analysed for features that predict local and distant recurrence.

Assessment is done for all enrolled patients to compare the quality of life after treatment with tomotherapy and conventional radiation . EORTC QLQC30 module will be used for evaluating QOL of patients. QOL scoring will be done as per standard recommendations outlined in EORTC QLQ C30 scoring manual. All patients will undergo QOL evaluation at baseline, after treatment and at subsequent follow-up. Scale- Not at all-1 , A little Bit-2, Quite a bit-3, very much-4.

1 will be considered as better outcome \& 4 will be considered as worst outcome.

Assessment is done for all enrolled patients to compare the quality of life after treatment with tomotherapy and conventional radiation. EORTC QLQCX24 module will be used to assess disease-specific and treatment-specific aspects of QoL in patients with cervical cancer. CX24 QOL scoring will be done as per standard recommendations outlined in EORTC QLQ CX24 scoring manual. All patients will undergo QOL evaluation at baseline, after treatment and at subsequent follow-up.

Scale- Not at all-1 , A little Bit-2, Quite a bit-3, very much-4.

1 will be considered as better outcome \& 4 will be considered as worst outcome.

Tata Memorial Hospital

Associate Professor

• 3D image-based cervical cancer brachytherapy will be delivered as 4 sessions x 7 Gy High Dose Rate (HDR) brachytherapy

Brachytherapy

This is non comparative prospective interventional study with some areas for observational research to implement based image guided adaptive cervical cancer brachytherapy ( BT ) combined with Intensity Modulated Radiotherapy ( IMRT ) / Volumetric Modulated Arc Therapy ( VMAT) external beam radiotherapy (EBRT) ± chemotherapy (ChT) , and to take advantage of its full potential.

* Eligible patients will receive both external beam radiotherapy ( EBRT) and concomitant chemotherapy and brachytherapy ( BT). Summation of EBRT and BT doses will be performed by calculation of a biologically equivalent dose in 2 Gy per fraction (EQD2) using the linear-quadratic model with α/β = 10 Gy for tumor effects and α/β = 3 Gy for late normal tissue damage. The repair half time is assumed to be 1.5 hrs.
* EBRT will be delivered as IMRT/VMAT with daily cone beam Computed Tomography ( CT ) Image Guided Radiotherapy (IGRT) in 25 fractions with 1.8 Gy to a total dose of 45 Gy given in 5 weeks.
* 3D image-based cervical cancer brachytherapy will be delivered as 4 sessions x 7 Gy High Dose Rate (HDR) brachytherapy , with ''Pre-radiotherapy Magnetic Resonance Imaging ( MRI ) examination'' to provide sufficient information about tumor extent in three dimension (3D) at the time of diagnosis and ''BT MRI examination'' is alse needed to provide sufficient information about tumor/target extent at the time of brachytherapy with the applicators in place .

For EBRT ; Using the cumulative Dose-volume histograms ( DVH ) to ensure that minimum dose to the target 95%, maximum dose limited to 107%, also, the dose to the organ at risk will be kept to the minimum according to the Radiation therapy oncology group ( RTOG ) recommendation.

For BT ; Dose volume adaptation will be performed with the aim of dose escalation in large tumors (prescribed D90 \> 85 Gy , Dose volume constraints (D2cc) were 70-75 Gy for rectum and sigmoid and 90 Gy for bladder.

Differential DVH, the dose standard deviations will be used to asses dose homogeneity.

The conformity index and dose gradient measure will be calculated . Collection of data : Data will be collected by doctor himself in Excel sheet . Statistics : numerical Data will be reported with mean , median , standard deviation \& variance and represented with suitable graph like histograms and frequency polygon . Discrete data will be analyzed with suitable tests like Chi-square test \& fisher's exact test and will represented with suitable graph like pie graph .

Inferential statistics will be reported with 95 confidence interval \& A P-value \<0.05 will be considered as statistically significant .

Survival analysis will be analyzed using the actuarial Kaplan Meier method , time will be calculated with date of diagnosis .

Data from patients who had not reached the endpoint at the time of last follow -up will be treated as censored observations

this study is gender based as it's aim is evaluation of image guided brachytherapy in management of cancer cervix which is disease limited to females .

Image Guided Brachytherapy in Locally Advanced Cancer Cervix

Implementation of Image Guided Brachytherapy in Treatment of Patients With Locally Advanced Cancer Cervix

Complete response , defined as the disappearance of all evidence of disease by physical examination and MRI pelvis

survival rates including disease free survival, overall survival

Sohag University

Fatma Ahmed Abdelfatah Rikabe

Assistant lecturer of clinical oncology

Nutritional and Metabolic Diseases

Malnutrition

Kwashiorkor

Nutrition Disorders

Severe Acute Malnutrition

Acute Graft Versus Host Disease

Micronutrients

All Drugs and Chemicals

Other Dietary Supplements

Amino Acids

Vitamins

Omega 3 Fatty Acid

Leucine

Valine

Isoleucine

ONS will be consumed 3 times a day, for 8 weeks. Per serving/sachet ONS (±81g) contains 350 kcal of energy, 9 g of fat, 20 g of protein, 48 g of carbohydrates, 400 mg of DHA (Docosahexaenoic acid), 300 mg of EPA (Eicosapentaenoic Acid) 0.92 g of Omega-3, 1 g of L-Valine, 2.1 g of L-. Isoleucine 1.1 g, L-Leucine 2.1 g, Sodium 75 mg, 12 vitamins and 9 minerals. Consumed as a morning snack (between breakfast and lunch); afternoon snack (between lunch and dinner) and evening snack (before bedtime). Subject will also received dietary counseling for 8 weeks

only received dietary counseling for 8 weeks without ONS supplementation.

Per serving/sachet NUTRICAN (±81g) contains 350 kcal energy, 9 g fat, 20 g protein, 48 g carbohydrate, 400 mg DHA, 300 mg EPA, 0.92 g Omega-3, 1 g L-Valine, 1.1 g L-Isoleucine, 2.1 g L-Leucine, 75 mg sodium, 12 vitamins and 9 minerals.

NUTRICAN

Sri AP Simanullang, B.Pharm

Dedyanto H Saputra, MD

Elisna Syahruddin, Prof.PhD,dr

Elisna Syahruddin, Phd.MD

The goal of this clinical trial is to evaluate the efficacy oral nutrition supplement (ONS) in malnutrition/high risk malnutrition cancer patients. The main questions it aims to answer:

1. Are there differences in knowledge, attitude and behaviour scores in cancer patients who receive cancer-specific ONS compared to those who do not receive cancer-specific ONS?
2. Is there a difference in nutritional status as assessed by average body weight, body mass index (BMI), haemoglobin (Hb), and albumin levels in cancer patients who receive cancer-specific ONS compared to those who do not receive cancer-specific ONS?

This study uses an open label randomized clinical trial (RCT) design, double arm which allows subjects and researchers to know the interventions received by subjects conducted on cancer patient subjects. The study aims to compare knowledge, attitudes, and actions related to nutrition consumption through questionnaires, nutritional status assessed from anthropometry (BW and BMI), nutrient intake, as well as laboratory results (Hb, serum albumin), quality of life, and inflammatory markers (CRP, TNF-α, IL(interleukin)-1, IL-6) between the group of subjects who were given dietary counseling and ONS/oral nutrition supplement (intervention group) for 8 weeks compared to the group of subjects who only received dietary counseling and did not receive ONS (control group).

Subjects who meet the inclusion criteria will be randomized into 2 groups using the stratified block randomization method stratified by age, and cancer type. Randomization will be carried out using a system in the application by stratifying the age of the subject based on the categorical age which has been categorized into 18-45 years and \>45 years. For the type of cancer stratified into two, namely lung cancer and gynecology cancer according to the inclusion criteria. Both stratified will be randomized using excel application that will randomize 80 subjects at the beginning of the research study.

Effect of NUTRICAN to Improve Nutritional Status in Cancer Patients

The Effect of Oral Nutrition Supplement Formulas (ONS) and Diet Counseling on Improvement of Nutritional Status, Knowledge, Attitudes, and Behavior of Cancer Patients

all IPD that underlie results in a publication

To determine changes in nutrition consumption knowledge scores in cancer patients who received cancer-specific ONS compared to those who did not receive ONS after 8 weeks of intervention using questioner .

Interpretation Knowledge score (5 questions): good (score\>=8 ) moderate (score 5-8) poor (score 0-4);

To determine changes in nutrition consumption attitudes score in cancer patients who received cancer-specific ONS compared to those who did not receive ONS after 8 weeks of intervention using questioner .

Interpretation Attitude score (10 questions): good (score\>=30 ) moderate (score 21-30) poor (score 0-20)

To determine changes in nutrition consumption behavior in cancer patients who received cancer-specific ONS compared to those who did not receive ONS after 8 weeks of intervention using questioner .

Interpretation Behaviour score(10 questions): good (score\>=30 ) moderate (score 21-30) poor (score 0-20).

To determine changes in BW (body weight in kg) in cancer patients who received cancer-specific ONS compared to those who did not receive ONS after the 8-week intervention. The higher the increase in BW, the better.

To determine changes in BMI (body mass index in kg/m2) in cancer patients who received cancer-specific ONS compared to those who did not receive ONS after the 8-week intervention. The higher the increase in BMI, the better.

BMI is calculated as weight in kilograms divided by the square of the height in meters (kg/m2) and is categorized into four groups according to the cutoff points: underweight (\<18.5 kg/m2), normal weight (18.5-22.9 kg/m2), overweight (23-24.9 kg/m2), obese grade 1 (≥25-29 kg/m2) and obese grade 2 (\>29 kg/m2)

To determine changes in Hb (haemoglobin in mg/dL) level in cancer patients who received cancer-specific ONS compared to those who did not receive ONS after the 8-week intervention. The higher the increase in haemoglobin level, the better.

To determine changes in Albumin level (g/dL) in cancer patients who received cancer-specific ONS compared to those who did not receive ONS after the 8-week intervention. The higher the increase in albumin level, the better

Changes in calorie intake between ONS group vs control group after an 8-week intervention. Assessment of calorie intake using NutriSurvey 2007, Food Recall 2x24h \& Food Record 3x24h. The higher subject's calorie (kcal) intake ,the better.

Changes in protein intake between ONS group vs control group after an 8-week intervention. Assessment of protein intake using NutriSurvey 2007, Food Recall 2x24h \& Food Record 3x24h. The higher subject's protein (gram) intake ,the better

The change in quality of life between ONS group vs control group; assessed by QLC-C30 (Quality of Life Questionnaire Core-30) score after 8 weeks of intervention. QLC-C30 is a 30 item instrument meant to assess some of the different aspects that define the quality of life of cancer patients.

Interpretation of QLC-C30 score: a.Good ≥1000 b.Moderate = 500-1000 c.Poor ≤500

The change in inflammatory status between ONS group vs control group assessed by CRP(C-reactive protein in mg/L) level (using CRP Latex Kit) after the 8-week intervention. The lower the value of CRP, the better.

The change in inflammatory status between ONS group vs control group assessed by IL-1 (interleukin-1 in pg/ml) level (using IL-1 ELISA kit) after the 8-week intervention The lower the value of IL-1, the better.

The change in inflammatory status between ONS group vs control group assessed by IL-6 (interleukin-6 in pg/ml) level (using IL-6 ELISA kit) after the 8-week intervention. The lower the value of IL-6, the better.

The change in inflammatory status between ONS group vs control group assessed by TNF-α (Tumor necrosis factor alpha in pg/ml) level (using Kit Quantikine ELISA Human TNF- α) after the 8-week intervention. The lower the value of TNF-α, the better.

Persahabatan Hospital

Kalbe International Pte. Ltd

Uterine Cervical Neoplasms

Each Focus Group of 10 women will be led by a psychologist according to a semi-directive interview pattern. This interview guideline specifies in details the ideal proceedings of Focus Group, as well as the various predetermined topics to be addressed in the form of questions and / or relaunches. The interview guideline is divided into 2 parts: the accompanying letter and the leaflet explaining how to perform the vaginal self-sampling.

Focus Group of 2 hours. Women will be asked to give their opinion about the communication media of the vaginal self-sampling kit.

Focus Group

Julie Boyard

Despite the existence of an effective screening test (pap smear), cervical cancer is, every year in France, the cause of more than 3,000 new cases and 1,100 deaths. But, in France, 4 in 10 women are not screened or not often enough (nearly 7 millions women). It is therefore necessary to develop new strategies to reach these women. The etiological factor of this cancer is persistent infection with oncogenic High-Risk Human PapillomaVirus (HR-HPV). Thereby, HPV-based tests could be alternative screening tests. Vaginal self-sampling with HR-HPV test is simpler and less intrusive than the pap smear. It has been shown that vaginal self-sampling with HPV test is a powerful means to increase the participation rate in cervical cancer screening. The investigators hypothesize that it is possible to optimize participation rate by improving the communication media associated to the vaginal self-sampling kit. This is why the accompanying letter and the leaflet explaining how to perform the vaginal self-sampling will be submit to women opinion by using the Focus Group method. The objective is to identify improvement ideas of these two communication media.

Carrying Out of Focus Group to Improve Cervical Screening Proposal by Vaginal Self-sampling (APACHE-4/FG).

The transcripts of the discussions will be reviewed by the psychologist to identify the emerging themes (anxiety, motivating information, ...) to identify levers and brakes and improve communication media.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Genomic Testing and Resulting Medical Decisions	NCT03301493	Cancer of Unkno... Cancer Refracto... Cancer of Stoma... Cancer Head Nec... Cancer of Skin Cancer, Lung Cancer Colorect... Cancer of Esoph... Cancer, Bladder Cancer, Uterus Cancer Cervix Cancer Liver Cancer, Kidney Cancer, Breast Hematologic Neo...	Genomic testing	18 Years -	Arbeitsgemeinschaft medikamentoese Tumortherapie
Tomotherapy vs Conventional Radiation for Adjuvant Pelvic RT in Ca Cervix	NCT01279135	Cancer Cervix	Conventional Ra... Tomotherapy bas...	18 Years -	Tata Memorial Hospital
Image Guided Brachytherapy in Locally Advanced Cancer Cervix	NCT04767425	Cancer Cervix	Brachytherapy	20 Years - 70 Years	Sohag University
Tomotherapy vs Conventional Radiation for Adjuvant Pelvic RT in Ca Cervix	NCT01279135	Cancer Cervix	Conventional Ra... Tomotherapy bas...	18 Years -	Tata Memorial Hospital
Effect of NUTRICAN to Improve Nutritional Status in Cancer Patients	NCT06128694	Malnutrition; P... Cancer, Lung Cancer Cervix	NUTRICAN	18 Years -	Kalbe International Pte. Ltd
Carrying Out of Focus Group to Improve Cervical Screening Proposal by Vaginal Self-sampling (APACHE-4/FG).	NCT03420157	Cancer Cervix	Focus Group	30 Years - 65 Years	University Hospital, Tours

Spots Global Cancer Trial Database for cancer cervix