Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Tissue Acquisition and Genomics Analysis of Breast Cancer and Other Gynecologic Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03762733
Recruitment Status : Not yet recruiting
First Posted : December 4, 2018
Last Update Posted : July 16, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Brief Summary:

Background:

A person s blood, tissue, and other samples contain DNA. Cancer is a disease of cells that are not working properly. It is caused by changes in DNA that build up. Researchers want to do future studies on DNA changes This may help them learn how to guide treatment for cancer. They need biological samples like tumors, blood, and urine for these studies.

Objective:

To create a place to collect and store biological samples from people with gynecologic malignancies like breast cancer. Samples from certain relatives of theirs will be collected too.

Eligibility:

Adults ages 18 and older who are being seen at NIH for breast cancer or other gynecologic malignancy

Their biological relatives of the same age

Design:

Participants will answer questions about their family history.

Participants will have a physical exam and medical history. This will include questions about age, ethnicity, and disease history. They will also answer questions about their medical treatments and responses.

Participants will give blood and urine samples.

Participants may give a tumor tissue sample. This will not be taken specifically for this study. It will be from a previous procedure or one that is already planned.

Other samples may be taken only if a procedure is required for treatment. These include bone marrow, cerebrospinal fluid, and other fluids.

A group of doctors and other professionals will oversee the sample storage place. The group will review all requests to be sure the use of the specimens is valid.


Condition or disease
Breast Cancer Ovarian Cancer Uterine Cancer

  Show Detailed Description

Layout table for study information
Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Tissue Acquisition and Genomics Analysis of Breast Cancer and Other Gynecologic Malignancies
Estimated Study Start Date : July 19, 2019
Estimated Primary Completion Date : December 29, 2023
Estimated Study Completion Date : December 29, 2023


Group/Cohort
Patient Relatives
Biological relatives (1st-3rd degree) of patients with histologically confirmed malignancy
Patients
Patients with histologically confirmed malignancy



Primary Outcome Measures :
  1. Establishment of a tissue repository for the collection and banking of tissue samples [ Time Frame: at study completion ]
    A tissue repository



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who are being seen in follow up, consultation, or presenting for enrollment on a clinical trial at the NIH Clinical Center
Criteria
  • INCLUSION CRITERIA:
  • Adult subject (age 18 and older)
  • Patient or biological relative of a patient, as follows:

    • Patient with a histologically confirmed breast cancer or other gynecologic malignancy; histopathology of the biopsy tissue must be confirmed by the NCI Laboratory of Pathology, prior to banking of the tissue on this protocol.
    • Biological relative (1st -3rd degree) of a patient who meets the eligibility of histologically confirmed malignancy per above criterion.
  • Subject willingness and ability to provide informed consent.
  • Subject willingness and ability to provide tissue samples for banking.

EXCLUSION CRITERIA:

- Pregnant subjects are eligible to take part; however, sample collection for those who are currently pregnant will only occur as follows:

  • No samples will be drawn for biobanking from a pregnant subject.
  • Primary treatment protocols exclude pregnant patients; therefore, no patient shall be pregnant on this biorepository protocol, while they continue on the treatment protocol; however, once the patient is no longer on the treatment protocol, there is no restriction to pregnancy for this protocol; but, as per the above criterion, no samples will be drawn for biobanking on a pregnant patient.
  • Biological relatives of a patient may not be pregnant at the time of consent and sampling; however, given that this is not a treatment protocol, there is no restriction on pregnancy beyond the time of donation of the samples to be banked (primarily blood for biological relatives)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03762733


Contacts
Layout table for location contacts
Contact: Rebecca S Trupp, R.N. (240) 760-7533 rebecca.trupp@nih.gov

Locations
Layout table for location information
United States, Maryland
National Institutes of Health Clinical Center Not yet recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office    888-624-1937      
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Christina M Annunziata, M.D. National Cancer Institute (NCI)

Additional Information:
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT03762733     History of Changes
Other Study ID Numbers: 190025
19-C-0025
First Posted: December 4, 2018    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: June 5, 2019

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Biobanking
Tissue Repository
Genetic Analysis

Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Uterine Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Diseases
Genital Diseases, Female