Neoplasms

All Conditions

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Adenocarcinoma

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Patients will receive germline testing and provide streck tube blood samples and archival tissue sample at baseline. After germline testing results have been generated and released, patients and clinicians will be contacted for survey completion at months: 1, 4, 8, 12, 18, 24, 30, 36, 42, 48, 54, 60 and survival collection every 6 months during years 3-10 post germline testing.

Patients will be offered enrollment into the sister trial, APOLLO (NCT04858334). Patients and clinicians will be contacted for survey completion at months: 1, 4, 8, 12, 18, 24, 30, 36, 42, 48, 54, 60 and survival collection every 6 months during years 3-5.

Germline genetic testing will be provided to each patient

Germline genetic testing

This study includes participants with pancreatic cancer who are undergoing genetic testing at Invitae related to their diagnosis of pancreatic cancer.

Our goal in this study is two-fold. First, we would like to research whether any inherited changes in genes may be associated with pancreatic cancer. Second, we would like to learn more about patient experiences with genetic testing, such as patient understanding of the testing, health-related actions taken (or planned to take) as a result of testing, communication and action of family members based on test results, and psychological impact of testing.

This research study involves allowing collection of tumor tissue (from a prior biopsy and/or surgery), a blood sample, and sending surveys to participants for their opinion on the impact of the genetic testing as well as clinicians for relevant baseline and medical history information.

Patients will be contacted for patient outcomes survey completion at months: 1, 4, 8, 12, 18, 24, 30, 36, 42, 48, 54, and 60. Patients will also be contacted for survival collection every 6 months during years 3-5 post germline testing.

Clinicians will be contacted for relevant medical history, treatment, and survival data at the same time points.

At baseline, 3 samples types will be collected: 1. EDTA tube for germline genetic testing. 2. Streck tubes for whole genome sequencing and other analyses. 3. Tumor block from surgical resection. If block is unavailable 10 unstained slides are an acceptable substitute.

Blood samples including EDTA tubes for germline testing, streck tubes for other analyses, and archival tissue sample from a previous biopsy or resection

ARTEMIS: Study of Patients With Early Stage Pancreatic Cancer Who Have Undergone Genetic Testing

ARTEMIS: A Prospective Study of Patients With Early Stage Pancreatic Cancer Who Have Undergone Genetic Testing

Invitae may share de-identified information and data generated through the study with third parties, including biopharmaceutical companies and biomedical researchers (e.g. academic), for clinical trials, drug development, and other disease-related research purposes.

Only a subset of Invitae personnel will have access to PHI. The PHI will be stored in a secure location and will only be made available to Invitae personnel involved in the Study. Any academic publication of data analysis from this Study will use de-identified information only.

Eastern Cooperative Oncology Group

Invitae Corporation

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Diseases and Abnormalities at or Before Birth

Breast Neoplasms

Syndrome

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Genetic Predisposition to Disease

Disease Susceptibility

Neoplastic Syndromes, Hereditary

Hereditary Breast and Ovarian Cancer Syndrome

Carcinoma

Genetic Diseases, Inborn

Breast Diseases

Skin Diseases

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Disease Attributes

Ovarian Cancer

Ovarian Epithelial Cancer

This sequential arm contains three types of communication to be employed following non-response to the previous type. The initial communication will be a direct message to the patient via the MyPennMedicine. The subsequent message will be sent as a text via the Way To Health app(lication). The final communication will be a nudge to the patient's physician which will send upon opening the patient's chart and will remain as a flag thereafter.

The intervention includes 3 message types: an EHR message, followed by a text message, followed by physician nudge. Each subsequent type will be activated if the previous type does not yield a response.

Sequential EHR Communications

The goal of this sequential study design is to increase genetic testing in those meeting national clinical guidelines. The main question it aims to answer is: which intervention is most effective in uptake of genetic testing for the target population? Participants will receive genetic testing and counseling that may initiate life-saving screenings.

Germline genetic testing is recommended by the National Cancer Center Network (NCCN) for individuals with a personal history of ovarian cancer, young-onset (\<50 years) breast cancer, and a family history of ovarian cancer or male breast cancer, among others. Recent publications demonstrate that the uptake of genetic testing is under-utilized, overall, and rates are consistently lower in minority populations. EHR-based algorithms will be used to identify patients of two Penn Medicine Ob/Gyn practices for whom genetic testing is recommended based on NCCN guidelines and to test pragmatic methods using messages delivered to patients or clinicians to encourage testing. The ACC Electronic Phenotyping Core developed the algorithms based on cancer registry data along with family history fields and this study will develop and test messages directed at patients and clinicians to encourage testing. The aims are:

1. Identification of at-risk populations through electronic health record (EHR) searches followed by patient nudges (MPM and then Way To Health) to increase the uptake of genetic counseling referral and testing in patients at gynecology practices at Dickens Center and Penn Medicine Radnor.
2. In patients who have not responded to patient nudges (Aim 1), test a provider nudge to increase the uptake of genetic counseling referral and testing in gynecology practices at Dickens Center and Penn Medicine Radnor (Aim 2).

Eligible patients will be sent a message through the patient portal to encourage genetic counseling and testing. If the patient does not respond, they will be sent a text message. Should there be no response, the patient's clinician will receive a nudge

Sequential EHR Based Interventions to Increase Genetic Testing for Breast and Ovarian Cancer Predisposition

Sequential EHR Based Interventions to Increase Genetic Testing for Breast and Ovarian Cancer Predisposition Across Diverse Patient Populations in Gynecology Practices at Penn Medicine

The total number of referrals signed by the patient's Ob/Gyn provider for genetic counseling and testing.

Scheduling and completion of genetic counseling appointments will be monitored through EHR. MPM stands for MyPennMedicine message which will be sent directly to the patient through the medical record.

Scheduling and completion of genetic counseling appointments will be monitored through EHR. The provider nudge will be delivered as a Best Practice Alert (BPA) upon opening the patient's chart.

The proportion of eligible participants who open the invitation to receive genetic counseling and testing compared to the total amount of eligible participants sent an MPM.

The proportion of eligible participants who respond to a text message invitation to receive genetic counseling and testing compared to the total amount of eligible participants sent a Way To Health (WTH) text.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
ARTEMIS: Study of Patients With Early Stage Pancreatic Cancer Who Have Undergone Genetic Testing	NCT05380557	Pancreatic Aden... Pancreatic Canc... Resectable Panc...	Germline geneti...	18 Years -	Invitae Corporation
Sequential EHR Based Interventions to Increase Genetic Testing for Breast and Ovarian Cancer Predisposition	NCT05721326	Genetic Predisp... Breast Cancer F... Ovarian Cancer Hereditary Brea... Hereditary Canc... Hereditary Dise... Gene Mutation-R...	Sequential EHR ...	25 Years - 100 Years	Abramson Cancer Center at Penn Medicine

Spots Global Cancer Trial Database for germline genetic testing