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Protocol Details

Inpatient Hospice with Procurement of Tissue on Expiration in Thoracic Malignancies, Bladder Cancer, Ovarian Cancer, Epithelial Cancer and Patients Treated with an Adoptive Cellular Therapy

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

13-C-0131

Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: 120 Years

Referral Letter Required

No

Population Exclusion(s)

Children;
Pregnant Women;
Fetuses

Keywords

Palliative;
Tumor Heterogeneity;
Genomic and Proteomic Alterations;
Deep Sequencing and Global Analysis;
Clonal Evolution;
Natural History

Recruitment Keyword(s)

None

Condition(s)

Thymus Tumors;
Adoptive Cellular Therapy;
Mesothelioma;
Genitourinary Cancers;
Lung Cancers

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Cancer Institute

Background:

- Individuals with cancer of the lung, chest cavity, ovary, or bladder, as well as patients who have been treated with adoptive cell therapy unfortunately commonly succumb to their disease. Some agree to donate their bodies to cancer research that may help the medical community better understand these diseases. Studies of cancer tumor tissue obtained soon after death may be used to answer questions about the origins, progression, and treatment of cancer. Researchers want to conduct a study that involves planned collection of cancer tumor tissue shortly after death. To do so, they will arrange to provide inpatient hospice care for people with lung cancer, ovarian cancer, bladder cancer, or patients who have been treated with adoptive cell therapy.

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Objectives:

- To collect cancer tissue biopsy samples as soon as possible after death.

Eligibility:

- Individuals who have cancer of the lung, chest cavity, ovary, or bladder, or those who have been treated with adoptive cell therapy and are planning to receive end-of-life hospice care are eligible to participate.

Design:

- Participants will agree to receive inpatient hospice care at the National Institutes of Health Clinical Center. Full details on end-of-life care preference will be acknowledged.

- An autopsy will be performed at the clinical center within 3 hours of death. Tumor tissue will be collected from the primary site of cancer and from any areas of the body to which the cancer has spread.

- Participants will not receive further cancer treatments as part of this study. This is a tissue collection study only.

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Eligibility

INCLUSION CRITERIA:

- Patients must have histologically or cytologically confirmed metastatic NSCLC, SCLC, EPCC, pNET, thymic epithelial tumor (thymoma, thymic carcinoma) or mesothelioma confirmed by the NCI Laboratory of Pathology. Patients with bladder cancer (including urothelial carcinoma and other rare bladder or kidney histology), ovarian cancer, epithelial cancers (breast, colorectal, pancreatic, stomach and biliary cancers) and malignancies previously treated with an ACT are also eligible.

- Age >= 18 years.

- Incurable disease or terminal diagnosis.

- Patients or legally authorized representative (LAR) must sign an informed consent indicating that they are aware of the investigational nature of this study.

- Patients must provide valid written designation of an assigned Durable Power of Attorney (DPA). If one is not available, an LAR must be assigned.

- Patients and their legal next of kin must agree to a Do Not Resuscitate (DNR) order and agree to Consent for Autopsy as part of the end-of-life care plan.

- This study was designed to include women and minorities, but was not designed to measure differences of intervention effects. Males and females will be recruited with no preference to gender. No exclusion to this study will be based on race. Minorities will actively be recruited to participate

EXCLUSION CRITERIA:

- Women known to be pregnant (known positive pregnancy test, although such testing is not required for enrollment) are excluded.

- Known HIV-positive patients will be excluded (although HIV testing is not required for enrollment) because of the potential for contamination of tissue.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Anish Thomas, M.D.
National Cancer Institute (NCI)
NIHBC 10 - CRC BG RM 4-5330
10 CENTER DR
BETHESDA MD 20892
(240) 760-7343
anish.thomas@nih.gov

Linda C. Sciuto, R.N.
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room 8D44
10 Center Drive
Bethesda, Maryland 20892
(240) 760-6117
linda.sciuto@nih.gov

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
1-888-NCI-1937

Clinical Trials Number:

NCT01851395

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