Breast NeoplasmsNCT00579163
Ascertainment of Peripheral Blood or Saliva Samples for Genetic Epidemiology Studies of Familial Cancers
An observational study of Breast Neoplasms and Ovarian Neoplasms, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to better understand the genetic causes of cancer and the inherited tendency to develop cancer. To accomplish this, blood specimens and/or saliva samples and/or tumor and normal tissue blocks from patients and families of patients with cancer will be collected. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Breast Neoplasms, Ovarian Neoplasms, Colonic Neoplasms
- How many people
- 992 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 1994to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Primary care clinic
Who may be able to join
- Patients accepted for referral to the Cancer Family Clinic of the Department of Medicine at Memorial Sloan-Kettering Cancer Center are eligible for participation in this study. Such patients should have a history of cancers of the breast, ovary, colon, prostate, uterus, non-Hodgkin's lymphoma, leukemia, soft tissue sarcoma, endocrine neoplasms, or other malignancies presenting in first degree relatives or in successive generations as part of a suspected cancer family syndrome.
- Family members of probands including parents, sisters, brothers, half-brothers and sisters, sons, daughters, grandparents, as well as aunts and uncles are also eligible.
- This study involves research which presents no greater than minimal risk to children. The assent of any minor should be obtained before the patient is entered into this study.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
The purpose of this study is to better understand the genetic causes of cancer and the inherited tendency to develop cancer. To accomplish this, blood specimens and/or saliva samples and/or tumor and normal tissue blocks from patients and families of patients with cancer will be collected. Blood specimens will be frozen and stored for analysis at a later date. Tumor tissue and normal tissue will be stored for analysis at a later date. In order to perform this study, patients and members of their families will be asked to provide blood samples and/or saliva samples. Individuals will be asked to provide a history of cancer in their relatives at the time the blood sample is given. No relatives will be contacted before they have been asked by a family member if they wish to participate in this study. If they do wish to participate, the relatives should indicate this by returning the "Family Member Consent for Contact Form" After we receive this form, arrangements may be made for the family member to send in a blood and/or saliva sample or to come in person to provide the sample to us.
Except for family history, no medical information provided by one member of a family will be discussed with other family members. At the end of this form, we will also ask for your permission to be contacted in the future to discuss information about your health, additional research with your samples and/or certain research findings possibly related to your sample.
Read the detailed description
Patients can provide either a blood or saliva sample for the protocol. For blood samples, two tubes of blood (approximately 20 cc) will be drawn from the patient, utilizing a sterile technique. The tubes will be rocked so as to mix the blood with the additive (EDTA) in the tubes. For saliva samples, approximately 2-4 ml of saliva will be collected in specialized Oragene DNA Self-Collection Kit tubes. The sample(s) may also be used to detect new genes or changes in genes that may tell us who is at risk for certain types of cancer and/or other diseases.
- Conditions
- Breast Neoplasms, Ovarian Neoplasms, Colonic Neoplasms, Prostatic Neoplasms, Uterine Cervical Neoplasms, Leukemia
- Keywords
- Blood, Salvia, Tissue
- Medical subject headings
- Breast Neoplasms, Ovarian Neoplasms, Colonic Neoplasms, Prostatic Neoplasms, Uterine Cervical Neoplasms, Leukemia, Lymphoma, Non-Hodgkin
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish a bank of DNA and frozen lymphoblastoid cell lines for the purpose of facilitating genetic epidemiology investigations of familial cancers.
Measured: 1 year
Secondary outcomes (1)
A related goal is to provide patients with cancer and their living relatives the opportunity to preserve DNA samples so that they may be used for future genetic counseling regarding inherited cancer risk.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2007 (estimated)
- Study startDec 1994
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 992 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kenneth Offit, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00579163
- Sponsor's protocol ID
- 93-102
- Status last verified
- Jan 2026
- First submitted
- 19 Dec 2007
- Last updated
- 7 Jan 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ascertainment of Peripheral Blood or Saliva Samples for Genetic Epidemiology Studies of Familial Cancers
- ClinicalTrials.gov ID
- NCT00579163
- Acronym / sponsor ID
- 93-102
- Conditions
- Breast Neoplasms, Ovarian Neoplasms, Colonic Neoplasms, Prostatic Neoplasms, Uterine Cervical Neoplasms, Leukemia
- Keywords
- Blood, Salvia, Tissue
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 992 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Dec 1994 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 21 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to better understand the genetic causes of cancer and the inherited tendency to develop cancer. To accomplish this, blood specimens and/or saliva samples and/or tumor and normal tissue blocks from patients and families of patients with cancer will be collected. Blood specimens will be frozen and stored for analysis at a later date. Tumor tissue and normal tissue will be stored for analysis at a later date. In order to perform this study, patients and members of their families will be asked to provide blood samples and/or saliva samples. Individuals will be asked to provide a history of cancer in their relatives at the time the blood sample is given. No relatives will be contacted before they have been asked by a family member if they wish to participate in this study. If they do wish to participate, the relatives should indicate this by returning the "Family Member Consent for Contact Form" After we receive this form, arrangements may be made for the family member to send in a blood and/or saliva sample or to come in person to provide the sample to us.
Except for family history, no medical information provided by one member of a family will be discussed with other family members. At the end of this form, we will also ask for your permission to be contacted in the future to discuss information about your health, additional research with your samples and/or certain research findings possibly related to your sample.
Detailed description
Patients can provide either a blood or saliva sample for the protocol. For blood samples, two tubes of blood (approximately 20 cc) will be drawn from the patient, utilizing a sterile technique. The tubes will be rocked so as to mix the blood with the additive (EDTA) in the tubes. For saliva samples, approximately 2-4 ml of saliva will be collected in specialized Oragene DNA Self-Collection Kit tubes. The sample(s) may also be used to detect new genes or changes in genes that may tell us who is at risk for certain types of cancer and/or other diseases.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (3 listed)
- Patients accepted for referral to the Cancer Family Clinic of the Department of Medicine at Memorial Sloan-Kettering Cancer Center are eligible for participation in this study. Such patients should have a history of cancers of the breast, ovary, colon, prostate, uterus, non-Hodgkin's lymphoma, leukemia, soft tissue sarcoma, endocrine neoplasms, or other malignancies presenting in first degree relatives or in successive generations as part of a suspected cancer family syndrome.
- Family members of probands including parents, sisters, brothers, half-brothers and sisters, sons, daughters, grandparents, as well as aunts and uncles are also eligible.
- This study involves research which presents no greater than minimal risk to children. The assent of any minor should be obtained before the patient is entered into this study.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To establish a bank of DNA and frozen lymphoblastoid cell lines for the purpose of facilitating genetic epidemiology investigations of familial cancers.
Time frame: 1 year
1 secondary outcome
A related goal is to provide patients with cancer and their living relatives the opportunity to preserve DNA samples so that they may be used for future genetic counseling regarding inherited cancer risk.
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth Offit, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasms and Ovarian Neoplasms, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To establish a bank of DNA and frozen lymphoblastoid cell lines for the purpose of facilitating genetic epidemiology investigations of familial cancers. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.