Nervous System Diseases

Heart and Blood Diseases

All Conditions

Symptoms and General Pathology

Stroke

Ischemic Stroke

Ischemia

Cerebrovascular Disorders

Brain Diseases

Central Nervous System Diseases

Vascular Diseases

Patients with active solid tumor cancer and acute ischemic stroke. Will undergo blood tests and transcranial Doppler microemboli detection study.

Patients with acute ischemic stroke and no cancer. Will undergo blood tests and transcranial Doppler microemboli detection study.

Patients with active solid tumor cancer and no stroke. Will undergo blood tests and transcranial Doppler microemboli detection study.

Study participants will undergo a single, peripheral blood draw. Blood specimens will be used to perform hematological biomarker testing and leukocyte RNA gene expression analysis.

Hematological biomarker testing will be performed to better elucidate the mechanisms of ischemic stroke in cancer patients and will include markers of coagulation, platelet function, and endothelial integrity. This analysis will occur at MSKCC.

Leukocyte RNA gene expression analysis will be performed to evaluate whether patients with cancer and stroke more often have cardioembolic mechanisms than patients with stroke and no cancer. This analysis will occur at the University of California, Davis where investigators have previously shown that differential RNA expression patterns can predict stroke subtypes.

Blood tests

Study participants will undergo a single Transcranial Doppler Microemboli Detection Study at NYPH/WCMC or MSKCC within two weeks of enrollment. Both middle cerebral arteries will be insonated for 30 minutes by a trained technician or stroke neurologist certified in neurosonology using a fixed headset to assess for the rate and laterality of microemboli.

Transcranial Doppler Microemboli Detection Study

Babak Navi, MD, MS

The purpose of this study is to better understand the causes of stroke in people with cancer. Active cancer increases the risk of stroke. The investigators do not know exactly why this occurs but one possible reason is that people with cancer may have thicker blood than people without cancer. Thick blood can sometimes cause blood clots to form in the heart, which can then travel to the brain and cause stroke. This study is being done to help figure out why this and other causes of stroke occur in people with cancer. The investigators expect that information from this study will help doctors to more effectively prevent and treat stroke in individuals with cancer.

This will be a prospective cross-sectional study to examine the unique mechanisms of ischemic stroke in cancer patients. Enrollment will occur at the NewYork-Presbyterian Hospital (NYPH)/Weill Cornell Medical Center (WCMC) and the Memorial Sloan Kettering Cancer Center (MSKCC). Measurements will occur at the NYPH/WCMC and MSKCC Neurovascular Ultrasound Laboratories, the MSKCC Central Laboratory, and the Sharp Laboratory at the University of California, Davis. Three groups of adult patients will be enrolled. Group 1 will consist of consecutive patients with active solid tumor cancer and acute ischemic stroke. Group 2 will be patients with acute ischemic stroke and no cancer. Patients in Groups 1 and 2 will be enrolled at 96 hours +/- 24 hours of stroke onset. Group 3 will include patients with active solid tumor cancer and no stroke. This group will allow us to confirm that differences between stroke patients with and without cancer are not simply incidental findings that can be expected in all cancer patients regardless of thrombotic status. Demographics, comorbidities, and stroke severity (for Groups 1 and 2 only) will be recorded on admission using a structured form. Study patients will undergo three facets of testing: 1) Transcranial Doppler (TCD) microemboli detection; 2) hematological biomarker testing; 3) peripheral blood leukocyte RNA gene expression analysis.

Mechanisms of Ischemic Stroke in Cancer Patients

With TCD studies, both middle cerebral arteries will be insonated for 30 minutes using a fixed headset. An experienced technologist will review the recording to ensure accurate characterization of all signals and a vascular neurologist with expertise in neurosonology will determine the rate and laterality of the microemboli. TCD microemboli in bilateral vascular distributions indicates a central embolic source.

Hematological testing will consist of a single peripheral blood draw at 96 hours (+/-24 hours). Several factors will be evaluated, including markers of coagulation (thrombin-antithrombin complex, D-dimer), platelet function (P-selectin), and endothelial integrity (sICAM-1, sVCAM-1, thrombomodulin).

Blood specimens will be collected at the time of enrollment in PAXgene tubes which will be frozen and stored at the Weill Cornell CTSC Core laboratory and sent in batches to the UC Davis laboratory where processing of RNA gene expression will occur.

University of California, Davis

Memorial Sloan Kettering Cancer Center

National Institute of Neurological Disorders and Stroke (NINDS)

Weill Medical College of Cornell University

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Infertility

Genital Diseases

Urogenital Diseases

All Drugs and Chemicals

Hormones

women 5-45 yr olf pre and post chemotherapy

time 0 is pretreatment time 3, 6 , 9, 12 months from the end of chemotherapy

blood tests

Ariel Revel, MD

young female cancer patients have improving chances of survival. the main risk is a chronic damage to their ovarian reserve. This may lead to future infertility.

our objective is to prospectively follow patients before and after their cancer treatment. this should help us learn of the gonadotoxicity of various treatments as well as be able to better consult these and future patients of the need of fertility preservation techniques.

Anti-Mullerian Hormone (AMH) and Antral Follicle Count as Markers of Ovarian Reserve- Prospective Followup of Young Cancer Patients

Phase 1 Prospective Study of Markers of Ovarian Reserve in Young Female Cancer Patients

Hadassah Medical Organization

Infections

Communicable Diseases

Retroviridae Infections

Virus Diseases

RNA Virus Infections

Study participants receiving gene therapy product at MD Anderson Cancer Center

If participant received retroviral gene therapy, blood test performed to check for a type of infection called the replication-competent retrovirus (RCR). Blood (up to 4 tablespoons each time) drawn every 3 months for first year after gene transfer therapy and once a year after that.

Blood Tests

Once a year during Years 1-5, questionnaire completions that asks about medical history (general health, the status of any medical conditions, and any illnesses or hospitalizations that may have occurred). It should take about 15-30 minutes to complete.

Once a year during Years 6-15, completion of mailed questionnaire. Participant will be asked about medical history (including if participant has had any children since the infusion) and whether there have been any changes in contact information. The questionnaires should take about 15-30 minutes each time.

Questionnaires

Partow Kebriaei, MD

The goal of this clinical research study is to collect information about the long-term safety of gene transfer therapy. This study is also designed to create a database of medical information about patients who have received gene transfer therapy, in order for researchers to track and review the long-term safety and any effects (good or bad) of gene transfer therapy.

Study Procedures for Years 1-5:

If you agree to take part in this study, you will come to the clinic for study visits once a year during Years 1-5. It is your choice whether to visit your regular local doctor or your study doctor at MD Anderson. (If you visit your regular local doctor, you will need to have your test results and blood samples mailed to the study staff.) You will receive a reminder phone call once a year, when it is time to schedule these visits.

At these visits, the following procedures will be performed:

* Blood (about 2-4 tablespoons each time) will be drawn for routine tests.
* You will have a physical exam, including measurement of your vital signs (blood pressure, heart rate, temperature, and breathing rate).
* You will fill out a questionnaire that asks about your medical history (your general health, the status of any medical conditions, and any illnesses or hospitalizations that may have occurred). It should take about 15-30 minutes to complete.
* You will be asked if there have been any changes in your contact information.
* If necessary to check the status of the disease, you will have scans (x-rays and/or computed tomography \[CT\] scans) and/or additional routine blood tests (about 1-2 tablespoons).

Study Procedures for Years 6-15:

Once a year during Years 6-15, the research staff will contact you. Either over the phone, by email, or by mail (but usually by mail, with an enclosed questionnaire), you will be asked about your medical history (including if you have had any children since the infusion) and whether there have been any changes in your contact information. The phone calls and questionnaires should take about 15-30 minutes each time.

Results of Study Testing:

If any of the tests that are performed in this study suggest that you may have a medical condition and/or side effect that is likely to be related to the gene transfer therapy, the study doctor will contact you. You will receive a referral in case you would like to seek medical care for the condition and/or side effect.

You and/or your insurance provider will be responsible for the costs of any CT scans and x-rays that may be needed for this study.

Study Database:

Your medical information that is collected for this study will be stored in a research database at MD Anderson for use in future research related to the safety and effects of gene transfer therapy.

Your data will be given a code number. No identifying information will be directly linked to your data. Only the researcher or authorized personnel in charge of the database will have access to the code numbers and be able to link the data to you. This is to allow medical information related to your data to be updated as needed. Other researchers using your data will not be able to link this data to you.

Changes in Parent/Guardian Contact:

If you are younger than 18 years old when joining this study but turn 18 during this study, starting then, the research staff will contact you directly for this study instead of your parent/guardian. However, if you would prefer for your parent/guardian to still be the main contact person, please tell the study staff.

Length of Study Participation:

After 15 years, your participation in this study will be over unless the FDA decides that follow-up must continue.

This is an investigational study.

Up to 130 patients will take part in this study. All will be enrolled at MD Anderson.

Study visits once a year during Years 1-5. Blood (about 2-4 tablespoons each time) drawn for routine tests. If retroviral gene transfer therapy received, blood (up to 4 tablespoons each time) drawn every 3 months for first year after gene transfer therapy and once a year after that. If joining study more than a year after gene transfer therapy, RCR test performed once a year for all 15 years of the study.

Long-Term Follow-Up of Recipient of Gene Transfer Research

Long-Term Follow-Up Study of Recipients of Gene Transfer Research Protocols

First 5 years following infusion of vector or vector-treated cells: Participants evaluated on annual basis. Years 6 to 15 following infusion of vector or vector-treated cells: Participants mailed questionnaires. Participants in retroviral studies: Up to 60 mL (max 1 mL/kg) blood will be obtained to check for replication-competent retrovirus (RCR) every 3 months during the first year, and then blood archived annually thereafter. Replication competent vector testing performed when there is a clinical indication or when requested by the FDA.

National Center for Research Resources (NCRR)

National Cancer Institute (NCI)

Alaunos Therapeutics

M.D. Anderson Cancer Center

Neoplasms

Prostatic Neoplasms

Neoplasm Metastasis

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases, Male

Prostatic Diseases

Male Urogenital Diseases

Blood tests for several bone markers (see summary)

Andre Bergman, MD, PhD

This registry aims to evaluate the efficacy of Rad-223 treatment in a non-study population of CRPC patients treated earlier with Docetaxel and patients not treated earlier with Docetaxel and efficacy of the first subsequent therapy. The indication for treatment with Radium-223 will be at the physician's decision. All patients treated with Radium-223 can be included in this registry. The registry only dictates the collection of base line characteristics, expansion of regular blood tests and patient reported pain scores.

Serum and blood markers of bone metabolism will be evaluated at Base Line, 1st, 2nd, 3rd and 6th (or last) Radium- 223 treatment. Every blood draw prior to Radium-223 treatment At baseline, tests include (but not restricted to): Testosterone, vitamin D-25-OH (Calciferol), C-reactive protein, Rank Ligand, IL6, BSAF, P1NP and CTX. Patients need to be fasting when blood is collected. (2x8,5 ml gel tube; Limited to 100 patients in selected centres). Before 2nd, 3rd, 4th and 6th (or last) Radium-223 treatment, tests include (but not restricted to): C-reactive protein, Rank, Ligand, IL6, BSAF, P1NP and CTX. Patients need to be fasting when blood is collected. (2x8,5 ml gel tube; Limited to 100 patients in selected centers).

Moreover, levels of osteoclast precursors (CD34+) will be evaluated (10 ml heparinized blood) prior to the first Radium-223 treatment, 3rd and last treatment (Limited to 100 patients in selected centres).

All above-mentioned blood collections will be from the same venipuncture as standard clinical labs. Experimental assessments will be evaluated for their value as biomarkers of treatment outcome.

Extra blood will be collected at baseline, 1st, 2nd, 3rd and 6th (or last) Radium-223 treatment. Changes in serum and blood levels of biomarkers of bone metabolism and levels of blood osteoclast precursors in Radium-223 treated patients will e evaluated for their potential to predict treatment outcome.

Treatment Outcomes in a Non-study Population of Symptomatic mCRPC Patients Treated With Radium-223

Registry of Treatment Outcomes in a Non-study Population of Symptomatic Metastasized Castration Resistant Prostate Cancer (mCRPC) Patients Treated With Radium-223

Evaluate Radium-223 treatment efficacy by patient, by several questionnaires (FACT-P, BPI-S and use of painmedication).

But also by patient records (records of bonescans, CT scans, blood measurements, out-patient clinic visits).

All of these assessments will be combined to come to a final reported value (Progressive disease, stable disease, partial remission or complete remission)

To evaluate the efficacy of Radium-223 treatment in a nonstudy population by effects on Symptomatic Skeletal Event (SSE). Through patient records and questionnairs (FACT-P, BPI-S and use of painmedication).

Evaluate Radium-223 treatment efficacy in a non-study population of CRPC patients by clinical parameters, through patient records (WHO PS)

Evaluate Radium-223 treatment tolerability in a non-study population of CRPC patients, through patient records (using the CTCAE v4.03 for adverse events).

Evaluate of the treatment after Radium-223 the treatment tolerability in a non-study population of CRPC patients, through patient records (using the CTCAE v4.03 for adverse events).

Identification of predictive clinical and explorative biomarkers of Radium-223 efficacy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Mechanisms of Ischemic Stroke in Cancer Patients	NCT02604667	Stroke Cancer	Blood tests Transcranial Do...	18 Years -	Weill Medical College of Cornell University
Anti-Mullerian Hormone (AMH) and Antral Follicle Count as Markers of Ovarian Reserve- Prospective Followup of Young Cancer Patients	NCT00930501	Infertility	blood tests	5 Years - 45 Years	Hadassah Medical Organization
Long-Term Follow-Up of Recipient of Gene Transfer Research	NCT01492036	Retroviridae In... Cancer	Blood Tests Questionnaires	-	M.D. Anderson Cancer Center
Mechanisms of Ischemic Stroke in Cancer Patients	NCT02604667	Stroke Cancer	Blood tests Transcranial Do...	18 Years -	Weill Medical College of Cornell University
Long-Term Follow-Up of Recipient of Gene Transfer Research	NCT01492036	Retroviridae In... Cancer	Blood Tests Questionnaires	-	M.D. Anderson Cancer Center
Treatment Outcomes in a Non-study Population of Symptomatic mCRPC Patients Treated With Radium-223	NCT03223727	Prostate Cancer... Bone Metastases	Blood tests	18 Years -	The Netherlands Cancer Institute
Mechanisms of Ischemic Stroke in Cancer Patients	NCT02604667	Stroke Cancer	Blood tests Transcranial Do...	18 Years -	Weill Medical College of Cornell University
Anti-Mullerian Hormone (AMH) and Antral Follicle Count as Markers of Ovarian Reserve- Prospective Followup of Young Cancer Patients	NCT00930501	Infertility	blood tests	5 Years - 45 Years	Hadassah Medical Organization

Spots Global Cancer Trial Database for blood tests

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

Spots Global Cancer Trial Database for blood tests

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

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