Neoplasms

All Conditions

Symptoms and General Pathology

Rare Diseases

Glioblastoma

Disease Progression

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

33% of the patients will be randomized to reirradiation (RT) alone. They will receive 36 Gy (2 Gy per fraction)

66% of the patients will be randomized to reirradiation (RT) + 400 mg APG101 weekly. They will receive 36 Gy (2 Gy per fraction) and 400 mg APG101 weekly as an intravenous infusion

APG101

Blood drawings, e.g. for safety labs, abdominal ultrasound, ECG. Re-Irradiation is not considered a study procedure, but standard of care (inclusion criterion)

Blood drawing

Wolfgang Wick, MD

This is a phase II study of APG101 + reirradiation (RT) versus reirradiation. Patients suffering from a malignant brain tumor called glioblastoma having a first or second progression can be included. They will be randomized to RT or RT + APG101.

APG101 is a fusion protein (similar to an antibody) and will be administered as a weekly infusion. Patients can stay in this study as long as they benefit from the participation (no fixed end).

In this trial, 30-35 sites in Germany, Austria and Russia take part.

In this phase II trial, patients with a recurrence / progression of glioblastoma (first or second progression) either not being eligible for tumour resection or having macroscopic residual tumour after resection of the recurrence can be included (tumor size must 1-4 cm in T1-weighted MRI). They must be candidates for a re-irradiation and will then be randomized in a 1:2 ratio to re-irradiation alone or re-irradiation + 400mg APG101 as a weekly intravenous infusion.

Radiotherapy (RT) is considered standard of care and not a study procedure. As prior therapies, a first radiotherapy (maximal dose of 60 Gy; at least 8 months since the end of preirradiation), a prior surgery (at least for histology) and at least one Temozolomide-containing chemotherapy are mandatory; patients with prior treatment with bevacizumab, iodine seeds and/or brachytherapy are not eligible. The patients' steroid dose must be stable or decreasing upon inclusion.

The number of patients to be included in this study is up to 83 (depending on the statistical 2-step SIMON design).

Primary objective: 6 months rate of progression free survival (PFS6). Subjects can participate in this study as long as a clinical benefit is considered by the treating physician.

MRI tumour imaging will be carried out every 6 weeks.

APG101 in Glioblastoma

A Phase II, Randomized, Open-label, Multi-centre Study of Weekly APG101 + Reirradiation Versus Reirradiation in the Treatment of Patients With First or Second Progression of Glioblastoma

Apogenix GmbH

Digestive System Diseases

Biliary Tract Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Biliary Tract Diseases

Gastrointestinal Diseases

Biliary Tract Cancer

Baseline blood samples will be collected from participants newly diagnosed with biliary tract cancer.

Baseline blood samples will be collected from participants newly diagnosed with benign biliary tract diseases.

Bin Li, MD/PhD

Yuzi Zhang, MD/PhD

Leibo Xu, MD/PhD

Xiaoqing Jiang, MD/PhD

ASCEND-BTC is a prospective, multi-center, observational study aimed at detecting early biliary tract cancer by combined assays of serum protein and cell-free DNA (cfDNA) methylation. The study will enroll approximately 492 participants diagnosed with biliary tract cancer and benign diseases.

Plasma, white blood cells and fresh frozen tumor tissue

AssesSment of Early-deteCtion basEd oN liquiD Biopsy in Biliary Tract Cancer (ASCEND-BTC)

Exploration and Validation of a Diagnosis Model for Biliary Tract Cancer Based on Combined Liquid Biopsy in Peripheral Blood: A Multi-center Prospective Study

Guangzhou Burning Rock Bioengineering Co., Ltd

Eastern Hepatobiliary Surgery Hospital

Director

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Immune System Diseases

Prostatic Neoplasms

Hypersensitivity

Neoplastic Cells, Circulating

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Neoplasm Metastasis

Neoplastic Processes

All Drugs and Chemicals

Hormones

Bo Dai, MD

As prostate cancer progresses, tumor cells dissociate and enter the bloodstream. Considered a "liquid biopsy," these circulating tumor cells (CTC) can show how a patient's cancer evolves and responds to treatments. The purpose of this study is to determine whether sequentially analyzing the expression of tumor markers in circulating tumor cells in newly diagnosed metastatic hormone-sensitive prostate cancer patients can predict the outcome of these patients.

Expression of Tumor Markers in Circulating Tumor Cells of Metastatic Hormone-sensitive Prostate Cancer

Development of a Prognostic Model for Metastatic Hormone-sensitive Prostate Cancer by Sequentially Analyzing the Expression of Tumor Markers in Circulating Tumor Cells

Fudan University

Clinical Professor of Department of Urology

Blood Drawing to measure circulating tumor cells counts.

Blood Drawing

The purpose of this study is to determine if a non-invasive cancer treatment, high-dose stereotactic body radiotherapy (SBRT), is associated with changes in circulating tumor cells counts in patients with low- and intermediate-risk prostate cancer.

SBRT (stereotactic body radiotherapy) may decrease or actually increase CTC levels in patients with cancer, and knowledge about the effects of different therapies, including SBRT, on CTC levels will be of general interest to the oncology community. Patients will undergo blood draws at defined times as indicated below.

1. Prior to CT-simulation, but more than 2 days after digital rectal examination
2. Within 24 hours following CT simulation (an endorectal balloon is used at the time of simulation)
3. Within 24 hours following the first treatment
4. Within 24 hours following the third treatment
5. Within 1 week following the fifth treatment

Circulating Tumor Cells in Prostate Cancer Patients

Circulating Tumor Cells in Patients Undergoing Stereotactic Body Radiotherapy for Low- and Intermediate-Risk Prostate Cancer

The investigator will review the coutns of circulating tumor cells (CTC). If there are significant changes in CTC levels with radiation, future studies will determine the prognostic significance of this information.

University of Texas Southwestern Medical Center

Infections

Skin and Connective Tissue Diseases

Blood and Lymph Conditions

Kidney Diseases

Communicable Diseases

Exanthema

Hematologic Diseases

Urologic Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Antineoplastic Agents

Anti-Infective Agents

Antirheumatic Agents

Dermatologic Agents

Everolimus

Cyclosporine

Cyclosporins

Itraconazole

Mycophenolic Acid

Tacrolimus

Sirolimus

Voriconazole

Clotrimazole

Miconazole

Fluconazole

Immunosuppressive Agents

Hydroxyitraconazole

Antifungal Agents

Posaconazole

Patients treated for their regular patient care with mycophenolic acid.

Patients treated for their regular patient care with cyclosporin.

Patients treated for their regular patient care with tacrolimus.

Patients treated for their regular patient care with sirolimus.

Patients treated for their regular patient care with everolimus.

Patients treated for their regular patient care with voriconazole.

Patients treated for their regular patient care with posaconazole.

Patients treated for their regular patient care with itraconazole.

Patients treated for their regular patient care with fluconazole.

The association between conventional venous sampling and finger prick dried blood spot (DBS) will be associated by drawing blood in both ways.

blood drawing

Roger Bruggemann, PharmD PhD

This is a clincial validation study of a dried blood spot (DBS) method for the analysis of immunosuppressive and antifungal agents currently subject of therapeutic drug monitoring (TDM) in a pediatric population.

The primary goal is to clinically validate a finger prick DBS method compared to conventional venous sampling for the analysis of 5 immunosuppressive and 4 azole antifungal drugs in the pediatric population. Secondairy goals include feasibility of the finger prick DBS method in the target population, to design an inventory of costs that will be incurred in future health-economic analyses and to construct a population PK model based on the available data collected for the primariy goal.

Therapeutic drug monitoring (TDM) offers the possibility to individualize and improve a patient's pharmacological treatment, based on the measurement of drug concentrations in biological samples. Conventionally, TDM is performed with blood or plasma obtained by venous blood sampling. This method is associated with several challenges such as i) the need for the patient to travel to the hospital or health center; ii) special conditions for sample transport to guarantee stability of the analyte and to decrease the biohazard risk; iii) sampling times not always representing the preferable peak or trough concentrations; iv) the method being invasive and v) delay of the outcome of the analyses with regard to the outpatient visit.

The Dried Blood Spot (DBS) may offer a solution for all these challenges. DBS is thought to offer benefits over plasma venous sampling for TDM. The main purpose of the PROTECT (Personalized treatment of immunosuppressive and antifungal drugs through continuous home based monitoring with Dried Blood Spot sampling techniques in pediatric patients) study is to improve therapeutic management and patient participation in pediatric patients treated with antifungal and immunosuppressive agents. PROTECT is mainly financed by a ZonMW grant 'Goed Gebruik Geneesmiddelen'.

Four patient organizations are actively involved in the PROTECT study.

Objective of the study:

Primairy To clinically validate a finger prick DBS method compared to conventional venous sampling for the analysis of 5 immunosuppressive and 4 azole antifungal drugs in the pediatric population. Secondairy

* Feasibility of the novel finger prick DBS method in the pediatric population will be assessed. This includes scoring of relevant characteristics (attributes) of blood drawing methods for TDM, evaluation of the experience and attitude of both patients and parents regarding finger prick DBS sampling and evaluation of the understanding of the written instructions provided for performing the finger prick at home. The data obtained in this validation study will be used for the implementation of the DBS in therapeutic drug monitoring (TDM) being a less invasive procedure, and as a base for a discrete choice-experiment as part of the HTA.
* To design an inventory of types of costs that will be incurred in the process of DBS-based and conventional TDM as a preparation step for later health economic analysis.
* Data from this study will be used to construct a population pharmacokinetic model to optimize dosing and design new guidelines.

This is an observational mono-centre study in which DBS sampling is compared with conventional sampling for TDM in a steady state situation.

Clearly, information on feasibility of DBS sampling in children and on costs relevant to DBS sampling in children can only be obtained through actual sampling in children.

Plasma without DNA, blood with DNA and dried blood spot (with DNA)

Clinical Validation of a Dried Blood Spot Method for Analysis of Immunosuppressives and Antifungals in Pediatrics

Clinical Validation of a Dried Blood Spot (DBS) Method for the Analysis of Immunosuppressive and Antifungal Drugs in Pediatric Patients (Part of the PROTECT Study).

The outcome measure is a composite of several blood concentrations, obtained by three individual blood drawing moments per patient. The related endpoint is the evaluation of the association between the concentration obtained by venous sampling and the concentration obtained by means of DBS sampling. The predictive performance of the DBS method as a measure for the venous concentration will be evaluated.

The related endpoint is the response to a questionnaire. Results will be used to prepare implementation of the novel method for home-based monitoring as well as to prepare a HTA analysis.

Costs of blood drawing methods will be collected.The cost types will function as a basis for future HTA analysis of this novel sampling method compared to conventional venous sampling.

Blood concentrations will be used to calculate the area under the concentration time curve (AUC). The outcome measure will be a composite of population estimates of the pharmacokinetic parameters AUC, maximal concentration (Cmax), time to maximal concentration (Tmax), clearance (CL), volume of distribution (Vd) and elimination half-life (t1/2).

ZonMw: The Netherlands Organisation for Health Research and Development

Radboud University Medical Center

Dai Bo, MD

As prostate cancer progresses into castration-resistant stage from initial hormone-sensitive status, the biological behavior of tumor cells that dissociated from primary lesions changed. Considered a "liquid biopsy," these circulating tumor cells (CTCs) can show how a patient's cancer responded to treatments. The purpose of this study is to determine whether sequentially analyzing the expression of molecular markers in high volume circulating tumor cells in metastatic castration-resistant prostate cancer patients can predict the therapeutic effects and outcomes of these patients.

Expression of Molecular Markers in Circulating Tumor Cells of Metastatic Castration-Resistant Prostate Cancer

Development of a Prognostic Model for High Volume Metastatic Castration-Resistant Prostate Cancer Patients by Sequentially Analyzing the Expression of Molecular Markers in Circulating Tumor Cells

Overall survival was defined as the period of time from inclusion to death from any cause, or to the last follow up date.

time from inclusion to prostate specific antigen (PSA) progression

time from inclusion to radiographic progression

prostate specific antigen response rate at 3 month and 6 month

Gland and Hormone Related Diseases

Pancreatic Neoplasms

Liver Neoplasms

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Hematinics

Liver Extracts

participants with liver, biliary tract, and pancreatic cancers

participants with liver, biliary tract, and pancreatic benign diseases

Participants with no known presence of malignancies or benign diseases

Yuan Ding, Phd

Weilin Wang, M.D.

Weilin Wang, Phd

LIBRARY is a prospective, multi-center, observational study aimed at detecting early liver, biliary tract, and pancreatic cancers by combining assays of cell-free DNA (cfDNA) methylation, serum protein, and microRNA.

LIBRARY is a prospective, multi-center, observational study aimed at detecting early liver, biliary tract, and pancreatic cancers by combining assays of cell-free DNA (cfDNA) methylation, serum protein, and microRNA. The study will enroll approximately 458 participants diagnosed with liver, biliary tract, and pancreatic cancers, 330 individuals with corresponding benign diseases and 820 healthy participants.

Early-stage Detection of LIver, Biliary tRAct and pancReatic Cancers

Early-stage Detection of LIver, Biliary tRAct and pancReatic Cancers by Liquid biopsY in Periphheral Blood: a Prospective Study (LIBRARY Study)

Guangzhou Burning Rock Dx Co., Ltd.

Second Affiliated Hospital, School of Medicine, Zhejiang University

Dr Alex Chang, MD

The proposal seeks to establish:

* A comprehensive compilation (database) of clinical information comprising clinical, histopathological, treatment and follow-up characteristics of past and future gastrointestinal cancer (GIC) cases in Singapore that can be shared by investigators. The characteristics will include clinical (eg age, sex, stage), histopathological (eg. grade, type), treatment (eg. treatment status, regimens) and outcome data (eg. survival, toxicity) from medical records.
* A collection (bank) of corresponding frozen and fixed tissue, blood and processed samples (enriched blood mononuclear cells, protein, RNA, DNA, tissue arrays) in Singapore that can be shared by the investigators.
* A gastrointestinal cancer co-operative group (GCCG) of clinicians and scientists researching prognostic and predictive markers in GIC, which will benefit from the multidisciplinary knowledge, information and samples of its members.

One of the current difficulties in the management of GIC is the decision to treat and the type of treatment to select. Tumour staging and histopathological assessment provides some indication of the likely aggressiveness of a cancer and hence the need to treat; however even within specific disease stages and histopathological types there is much variability in disease outcomes and further sub-categorization is desirable. For the type of treatment to select, there are currently no established criteria, despite the fact there is much inter-individual variability in response rates and the occurrence of drug toxicity. Currently this has also become an increasingly important issue as the numbers of available regimens for GIC chemotherapy such as 5-FU, capecitabine, irinotecan, oxaliplatin, gefitinib, erlotinib, cetuximab, and bevacuzimab either alone or in combination has recently increased, making the treatment selection even more difficult. There is clearly a need for additional prognostic (predictive of disease aggressiveness) and predictive (predictive of likely response to treatment) indicators for GIC.

In over 10 years devoted to developing prognostic and predictive markers in different laboratories and clinics in Australia, Singapore, Europe and USA, the PI has gained deep experience in what it takes to run a successful program for the development of prognostic and predictive markers (Soong et al. 1996, Soong et al. 2000, Mattison et al. 2002).

Firstly needed is a comprehensive database linking clinical, histopathological, treatment and outcome characteristics of each case. This provides multiple functional endpoints to understand the significance of the candidate marker and a complete overview of likely influencing factors.

Secondly needed is a collection of samples linked to the database that are suitable for the testing of candidate markers. In this regard, the types of samples analyzed are also critical:

In the last few years, the distinction between prognostic and predictive markers has been found to be increasingly important (Elsaleh et al. 2000). Some cancers may be aggressive (poor prognosis) but respond well to treatment giving the appearance of good outcome, while others may be relatively benign (good prognosis) but resistant to treatment, giving a poor outcome. Without taking this into consideration, some markers considered to be markers of poor prognosis may be actual markers of poor treatment response but good prognosis, and all the other possible misleading permutations. The methods to clearly delineate prognostic and predictive significance have now been defined: Prognostic significance for a marker is determined by examining its associations with survival in patients without treatment. Predictive significance is determined by comparing the survival of patients with treatment against those without in patient subgroups with and without the candidate marker. The significance of this is that to clearly develop prognostic and predictive markers, investigators need a group of cases that has not received treatment. Since the mid-1990s, chemotherapy became a mainstay for advanced GIC cancer and it is now considered unethical not to treat, implying the only way to accurately assess a marker on its prognostic or predictive significance is to analyze samples pre-mid 1990s with a recording of their treatment status, and this can be obtained from archived fixed tissue collections.

The other sample consideration is that to integrate well into clinical practice, prognostic and predictive markers preferably are analyzable on non-invasive samples and are able to be proven in prospective analysis. The collection of minimally-inconveniencing blood samples would serve this purpose, and to have sufficient sample size available for the validation of future prognostic and predictive markers, it would be provident to begin collection as early as possible.

Thirdly, to have sufficient statistical power and understand the complexity of the disease from various angles of expertise in the management of GIC, cross-department and -institutional collaboration is necessary.

These factors have gone into the proposal of the specific objectives of this current protocol given above.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
APG101 in Glioblastoma	NCT01071837	Glioblastoma Mu...	APG101 Blood drawing	18 Years -	Apogenix AG
AssesSment of Early-deteCtion basEd oN liquiD Biopsy in Biliary Tract Cancer (ASCEND-BTC)	NCT05667350	Biliary Tract C...	Blood drawing Blood drawing	40 Years - 75 Years	Eastern Hepatobiliary Surgery Hospital
Expression of Tumor Markers in Circulating Tumor Cells of Metastatic Hormone-sensitive Prostate Cancer	NCT02723526	Prostate Cancer	Blood drawing	18 Years - 80 Years	Fudan University
Circulating Tumor Cells in Prostate Cancer Patients	NCT01414712	Prostate Cancer	Blood Drawing	18 Years - 99 Years	University of Texas Southwestern Medical Center
Clinical Validation of a Dried Blood Spot Method for Analysis of Immunosuppressives and Antifungals in Pediatrics	NCT02329808	Hematologic Dis... Oncology Proble... Kidney Diseases Transplantation...	blood drawing	2 Years - 18 Years	Radboud University Medical Center
Expression of Molecular Markers in Circulating Tumor Cells of Metastatic Castration-Resistant Prostate Cancer	NCT03089099	Prostate Cancer...	Blood drawing	18 Years - 80 Years	Fudan University
Expression of Molecular Markers in Circulating Tumor Cells of Metastatic Castration-Resistant Prostate Cancer	NCT03089099	Prostate Cancer...	Blood drawing	18 Years - 80 Years	Fudan University
Early-stage Detection of LIver, Biliary tRAct and pancReatic Cancers	NCT06139042	Liver Cancer Biliary Tract C... Pancreatic Canc...	Blood drawing	40 Years - 75 Years	Second Affiliated Hospital, School of Medicine, Zhejiang University
Infrastructure for Developing Gastrointestinal Cancer Prognostic and Predictive Markers	NCT00539318	Gastrointestina...	Blood drawing	18 Years -	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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