Hereditary Breast CarcinomaNCT07887620
Chatbot Utilization for Pedigree Creation and Cancer Risk Assessment in Cancer Genetic Counseling
A study testing Text Message -based Navigation Intervenion and Artificial Intelligence based Intervention in people with Hereditary Breast Carcinoma and Hereditary Malignant Neoplasm, run by Roswell Park Cancer Institute at 1 site in United States.
Trial summary
This clinical trial studies whether a chatbot can be used to help collect medical history and perform cancer risk assessment among patients undergoing cancer genetic counseling. With the improved cost of genetic testing and growing utilization of genetics in cancer care and risk assessment, there is growing pressure… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hereditary Breast Carcinoma, Hereditary Malignant Neoplasm
- What is being tested?
- Text Message -based Navigation Intervenion and Artificial Intelligence based Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to 1 Nov 2027
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- PATIENT PARTICIPANTS: Age 18 years or greater
- PATIENT PARTICIPANTS: Scheduled as a new patient appointment to see a certified genetic counselor at the Roswell Park Comprehensive Cancer Center (either in person or for a virtual appointment)
- PATIENT PARTICIPANTS: Written and spoken fluency in English
- PATIENT PARTICIPANTS: Able to understand the consenting process and willing to participate in the study
- GENETIC COUNSELOR PARTICIPANTS: Any genetic counselor who sees patients for initial genetics consultation at Roswell Park Comprehensive Cancer Center is eligible to participate in the study
Who cannot join
- Prior germline genetic testing for a hereditary cancer predisposition
- First or second-degree family member with a known pathogenic variant, likely pathogenic variant, or variant of uncertain significance in a gene associated with cancer predisposition
- Scheduled to see a genetic counselor who has not give
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14203
ASK RPCI, 877-275-7724, AskRoswell@Roswellpark.org
About this study
This clinical trial studies whether a chatbot can be used to help collect medical history and perform cancer risk assessment among patients undergoing cancer genetic counseling. With the improved cost of genetic testing and growing utilization of genetics in cancer care and risk assessment, there is growing pressure placed on certified genetic counselors. To address this issue, many have turned to artificial intelligence (the branch of computer science that deals with writing computer programs that can solve problems creatively) for practical solutions to re-distribute the workload of certified genetic counselors. The chatbot in this trial uses artificial intelligence technology to analyze information provided by the patient during a phone call. The chatbot then generates a family history summary, family tree (pedigree), and cancer risk related assessments, which may help redistribute the workload for the certified genetic counselor and ultimately make genetic counseling more accessible. Using a chatbot may be helpful in collecting medical history and determining cancer risk assessment among patients undergoing cancer genetic counseling.
Read the detailed description
PRIMARY OBJECTIVE:
- To assess the sensitivity and specificity of a chatbot's determination of meeting National Comprehensive Cancer Network (NCCN) criteria for germline genetic testing compared to a certified genetic counselor's determination
SECONDAY OBJECTIVES:
- To assess the reliability and accuracy of a chatbot-generated cancer-focused family pedigree as determined by a certified genetic counselor.
II. To determine the sensitivity and specificity of a chatbot-generated Tyrer-Cuzick determination of breast cancer risk.
III. To evaluate the proportion of patients in a genetic counseling clinic population with greater than 20% lifetime risk of breast cancer and/or criteria met for germline genetic testing.
IV. To evaluate patient satisfaction using a chatbot for family history collection and breast cancer risk assessment.
- To evaluate provider satisfaction with use, accuracy, and clinical workflow of chatbot-derived data.
OUTLINE:
Patients receive a text message with chatbot phone number at baseline. Patients then complete a phone call with the chatbot over 10-20 minutes consisting of a structured, genetics-specific interview and receive a chatbot generated provider summary, pedigree/structured data, NCCN flag, and Tyler-Cuzick score, which are routed to clinical team up to 21 days before scheduled genetics appointment.
- Being tested
- Text Message -based Navigation Intervenion, Artificial Intelligence based Intervention
- Medical subject headings
- Breast Cancer, Familial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text Message -based Navigation IntervenionOther
Receive chatbot phone number text message
Artificial Intelligence based InterventionOther
Complete chatbot phone call
| Study group | Role | What they receive |
|---|---|---|
| Screening - chatbox call | Experimental | Patients receive a text message with chatbot phone number at baseline. Patients then complete a phone call with the chatbot over 10-20 minutes consisting of a structured, genetics-specific interview and receive a chatbot generated provider summary, pedigree/structured data, NCCN flag, and Tyler-Cuzick score, which are routed to clinical team up to 21 days before scheduled genetics appointment. Receives: Other: Text Message -based Navigation Intervenion; Other: Artificial Intelligence based Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of chatbot in determining if patient meets National Comprehensive Cancer Network (NCCN) criteria for germline genetic testing
Will assess the sensitivity of a chatbot in determining if a patient meets NCCN criteria for germline genetic testing compared to the gold standard of a certified genetic counselor's (CGC's) determination
Measured: Up to 21 days before genetics appointment
Secondary outcomes (4)
Accuracy of chatbot generated family history pedigree
Graded by a CGC on a five point scale with 1 = entirely unreliable to 5 = no clinically meaning full errors.
Measured: Up to 21 days before genetics appointment
chatbot generated Tyrer Cuzick determination of breast cancer risk
To assess chatbot's determination of whether patient's lifetime breast cancer risk is estimated at greater than 20% utilizing the Tyrer-Cuzick algorithm
Measured: Up to 21 days before genetics appointment
Proportion of patients with greater than 20% lifetime breast cancer risk
Assessed by the Tyrer-Cuzick model
Measured: Up to 21 days before genetics appointment
Patient satisfaction survey with using a chatbot
Self administered Patient survey assessing satisfaction of using chatbot with responses ranging from strongly agree to Strongly disagree
Measured: Up to 7 days after genetics appointment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hereditary Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 129 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07887620
- Sponsor's protocol ID
- I-4840126
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chatbot Utilization for Pedigree Creation and Cancer Risk Assessment in Cancer Genetic Counseling
- ClinicalTrials.gov ID
- NCT07887620
- Acronym / sponsor ID
- I-4840126
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 129 participants (estimated)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 21 Oct 2026 (actual)
- 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.
This clinical trial studies whether a chatbot can be used to help collect medical history and perform cancer risk assessment among patients undergoing cancer genetic counseling. With the improved cost of genetic testing and growing utilization of genetics in cancer care and risk assessment, there is growing pressure placed on certified genetic counselors. To address this issue, many have turned to artificial intelligence (the branch of computer science that deals with writing computer programs that can solve problems creatively) for practical solutions to re-distribute the workload of certified genetic counselors. The chatbot in this trial uses artificial intelligence technology to analyze information provided by the patient during a phone call. The chatbot then generates a family history summary, family tree (pedigree), and cancer risk related assessments, which may help redistribute the workload for the certified genetic counselor and ultimately make genetic counseling more accessible. Using a chatbot may be helpful in collecting medical history and determining cancer risk assessment among patients undergoing cancer genetic counseling.
Detailed description
PRIMARY OBJECTIVE:
- To assess the sensitivity and specificity of a chatbot's determination of meeting National Comprehensive Cancer Network (NCCN) criteria for germline genetic testing compared to a certified genetic counselor's determination
SECONDAY OBJECTIVES:
- To assess the reliability and accuracy of a chatbot-generated cancer-focused family pedigree as determined by a certified genetic counselor.
II. To determine the sensitivity and specificity of a chatbot-generated Tyrer-Cuzick determination of breast cancer risk.
III. To evaluate the proportion of patients in a genetic counseling clinic population with greater than 20% lifetime risk of breast cancer and/or criteria met for germline genetic testing.
IV. To evaluate patient satisfaction using a chatbot for family history collection and breast cancer risk assessment.
- To evaluate provider satisfaction with use, accuracy, and clinical workflow of chatbot-derived data.
OUTLINE:
Patients receive a text message with chatbot phone number at baseline. Patients then complete a phone call with the chatbot over 10-20 minutes consisting of a structured, genetics-specific interview and receive a chatbot generated provider summary, pedigree/structured data, NCCN flag, and Tyler-Cuzick score, which are routed to clinical team up to 21 days before scheduled genetics appointment.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screening - chatbox call | Experimental | Other: Text Message -based Navigation Intervenion, Other: Artificial Intelligence based InterventionPatients receive a text message with chatbot phone number at baseline. Patients then complete a phone call with the chatbot over 10-20 minutes consisting of a structured, genetics-specific interview and receive a chatbot generated provider summary, pedigree/structured data, NCCN flag, and Tyler-Cuzick score, which are routed to clinical team up to 21 days before scheduled genetics appointment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- PATIENT PARTICIPANTS: Age 18 years or greater
- PATIENT PARTICIPANTS: Scheduled as a new patient appointment to see a certified genetic counselor at the Roswell Park Comprehensive Cancer Center (either in person or for a virtual appointment)
- PATIENT PARTICIPANTS: Written and spoken fluency in English
- PATIENT PARTICIPANTS: Able to understand the consenting process and willing to participate in the study
- GENETIC COUNSELOR PARTICIPANTS: Any genetic counselor who sees patients for initial genetics consultation at Roswell Park Comprehensive Cancer Center is eligible to participate in the study
Key exclusion criteria (3 listed)
- Prior germline genetic testing for a hereditary cancer predisposition
- First or second-degree family member with a known pathogenic variant, likely pathogenic variant, or variant of uncertain significance in a gene associated with cancer predisposition
- Scheduled to see a genetic counselor who has not give
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Text Message -based Navigation IntervenionReceive chatbot phone number text message | Other | Screening - chatbox call |
| Artificial Intelligence based InterventionComplete chatbot phone call | Other | Screening - chatbox call |
Primary outcome
Sensitivity and specificity of chatbot in determining if patient meets National Comprehensive Cancer Network (NCCN) criteria for germline genetic testing
Time frame: Up to 21 days before genetics appointment
Will assess the sensitivity of a chatbot in determining if a patient meets NCCN criteria for germline genetic testing compared to the gold standard of a certified genetic counselor's (CGC's) determination
4 secondary outcomes
Accuracy of chatbot generated family history pedigree
Time frame: Up to 21 days before genetics appointment
chatbot generated Tyrer Cuzick determination of breast cancer risk
Time frame: Up to 21 days before genetics appointment
Proportion of patients with greater than 20% lifetime breast cancer risk
Time frame: Up to 21 days before genetics appointment
Patient satisfaction survey with using a chatbot
Time frame: Up to 7 days after genetics appointment
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 27 Oct 2026.
Related trials for Hereditary Breast Carcinoma
Enrolling by invitationObservational study
Advanced Ultrasound Signal Processing of Suspicious Breast Images
Breast Cancer, Breast Cyst
Active, not recruiting
Culturally-Informed Counseling in Latinas at High Risk for Hereditary Breast or Ovarian Cancer
No Evidence of Disease, BRCA1 Syndrome
Not yet recruiting
Management of Breast Fibroadenoma: Comparing Observation, Microwave Ablation, and Surgical Excision
Fibroadenoma, Breast Fibroadenoma
RecruitingPhase 3
The Cancer of the Pancreas Screening-5 CAPS5)Study
Pancreas Cancer, Peutz-Jeghers Syndrome (PJS)
Not yet recruiting
Ovarian Cancer Liquid Biopsy for Early Assessment & Detection in Individuals With BRCA1/2 Pathogenic Variants
Ovarian Neoplasms, BRCA 1 Gene Mutation
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.
Roswell Park Comprehensive Cancer Center
Buffalo, United States
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Text Message -based Navigation Intervenion and Artificial Intelligence based Intervention in people with Hereditary Breast Carcinoma and Hereditary Malignant Neoplasm, run by Roswell Park Cancer Institute 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 5 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 27 Oct 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of chatbot in determining if patient meets National Comprehensive Cancer Network (NCCN) criteria for germline genetic testing (time frame: Up to 21 days before genetics appointment). 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 27 Oct 2026.