New study aims to break language and cultural barriers in cancer genetic testing
NCT ID NCT04751435
First seen Jun 27, 2026 · Last updated Jul 22, 2026 · Updated 2 times
Summary
This study aims to create and improve educational materials about genetic testing for cancer patients from diverse backgrounds. Researchers will interview 445 people with breast, ovarian, pancreatic, prostate, or colorectal cancer who speak English, Spanish, or Haitian Creole. The goal is to make genetic testing information easier to understand and more culturally appropriate, so all patients can make informed decisions about their care.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 445 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2021
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Phase 1 * Age ≥ 18 years as per self-report * Current or previous diagnosis of breast, ovarian, pancreatic, or prostate cancer as per self-report * Self-identification as Black, Latino, and/or neither Black nor Latino (i.e.,non-Latino, Non black) * Fluency in English, Haitian Creole, or Spanish as per self-report (for Spanish, we will attempt to recruit a cohort representing a variety of regions where Spanish is spoken, as informed by current data from participating sites, to achieve neutrality in the language) Fluency is defined as an answer of "well" or "very well" on the screening questions for spoken and reading ability. Phase 2: * Age ≥ 18 years as per the medical record and/or clinician referral * Current or previous diagnosis of breast, colorectal, ovarian, pancreatic, or prostate cancer meeting at least one of the applicable criteria for the cancer type as per the medical record and/or clinician referral: * Breast cancer criteria: * any diagnosis age 65 or younger; * diagnosis of triple negative breast cancer at any age; * multiple primary breast cancers at any age; * under consideration for PARP therapy; * any family history (1st, 2nd, or 3rd degree relatives) of ovarian or pancreas cancer, or 1 relative with breast cancer who meets the above criteria, or 2 relatives with breast cancer at any age; or clinician discretion) * Colorectal cancer criteria: * any diagnosis age 50 and below; * mismatch repair deficient colorectal cancer; * colorectal cancer at any age with an additional Lynch syndromerelated primary cancer at any age; * colorectal cancer at any age with a 1st or 2nd degree relative with colorectal cancer at/before age 50; * colorectal cancer at any age with 2 or more 1st or 2nd degree relatives with a Lynch syndrome-related cancer at any age * Ovarian cancer criteria: ° invasive ovarian cancer * Pancreatic cancer criteria: ° pancreatic adenocarcinoma * Prostate cancer criteria: * castrate-resistant, metastatic prostate cancer; * high-risk prostate cancer (pending pathology definition) * Fluency in English, Haitian Creole, or Spanish as per self-report. Fluency is defined as an answer of "well" or "very well" on the screening questions for spoken ability * No prior cancer genetic counseling or germline testing for cancer risk as per self-report clinician's note, and/or no clinical documentation Exclusion Criteria: Phase 1: * Individuals of impaired decision-making capacity as per a clinician's or consenting professional's judgment. * Subjects who indicate level of fluency as "not at all" or "not well". Phase 2: * Individuals of impaired decision-making capacity as per a clinician's or consenting professional's judgment. * Subjects who indicate level of fluency as "not at all" or "not well".
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Jamaica Hospital Medical Center (Data Collection Only)
RECRUITINGRichmond Hill, New York, 11418, United States
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Kings County Hopsital Center
RECRUITINGBrooklyn, New York, 11203, United States
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Memorial Sloan Kettering at Ralph Lauren Center (Limited Protocol Activities)
RECRUITINGNew York, New York, 10035, United States
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Queens Cancer Center of Queens Hospital
RECRUITINGJamaica, New York, 11432, United States
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