Clinical Cancer Genomics Research Program

IRB# 96144: Assessing for genetic risk factors for cancer risk, etiologies of cancer, clinical outcomes for individuals with germline or hereditary or familial cancer risk

Principal investigator: Stephen Gruber, M.D., Ph.D., M.P.H.
Study coordinator: Lorena Reynaga
For more info, contact ccgcrn@coh.org

IRB# 96144: This study is trying to identify 1) cancer risk or penetrance for people with TP53 variants, 2) modifiers of TP53 cancer risk, and 3) prevalence and clinical outcomes of people with TP53 mosaicism vs. germline vs. CHIP.

AIM 1
To gather preliminary data on cancer patients’ knowledge of cancer genetic concepts and knowledge about defining characteristics of their disease (e.g., stage, genomic alterations)

AIM 2
To design and pilot test a dynamic, patient-facing web-based cancer genome sequencing education platform and genomic report — HOPE-Genomics — that pulls and displays individual, patient-level genomic data from either 1) the electronic health record or 2) institutional pathology databases

Principal investigator: Stephen Gruber, M.D., Ph.D., M.P.H.
Study coordinator: Bita Nehoray, bnehoray@coh.org

Patient Enrollment Qualifications

Individuals with a likely pathogenic or pathogenic variant in the TP53 gene in themselves or a family member (some VUS may be eligible on a case-by-case basis)

For more info, email dl-liftup@coh.org

IRB# 17032
AIM 1
To gather preliminary data on cancer patients’ knowledge of cancer genetic concepts and knowledge about defining characteristics of their disease (e.g., stage, genomic alterations)

AIM 2
To design and pilot test a dynamic, patient-facing web-based cancer genome sequencing education platform and genomic report — HOPE-Genomics — that pulls and displays individual, patient-level genomic data from either 1) the electronic health record or 2) institutional pathology databases

Principal investigator: Stacy W. Gray, M.D., A.M.
Study coordinator: Marilan Luong, mluong@coh.org

Patient Enrollment Qualifications

• Age ≥ 18 years
• Confirmed pathogenic germline variant and medically actionable somatic alteration identified within patient’s medical record
• Has access to an electronic device with internet

For more info, email mluong@coh.org

IRB# 17032
AIM 1
Test the efficacy of the HOPE-Genomics intervention in improving patient knowledge of genomics (recall rates)

AIM 2
Test the efficacy of the HOPE-Genomics intervention in improving patient receipt of guideline-concordant care

Principal investigator: Stacy W. Gray, M.D., A.M.
Study coordinator: Marilan Luong, mluong@coh.org

Patient Enrollment Qualifications

• Age ≥ 18 years
• English-speaking patients will be eligible if they:
  • Are enrolled in IRB# 07047
  • Have a diagnosis of lung, breast, colorectal, pancreatic, ovarian or prostate cancer
  • They have somatic, germline or paired somatic or germline sequencing
  • They have an ECOG performance status of 0-2

For more info, email mluong@coh.org

IRB# 19594: To assess the frequency of germline cancer susceptibility mutations in affected and unaffected individuals with a personal or family history suggestive of high lung cancer risk

Principal investigator: Stacy W. Gray, M.D., A.M., and Dan J. Raz, M.D., M.A.S.
Study coordinator: Marilan Luong, mluong@coh.org
 

Patient Enrollment Qualifications

• Age ≥ 18 years
• English, Spanish or Mandarin-speaking patients who are patients at City of Hope will be eligible if they:
  1. Have had lung cancer and at least one of the following:
     • Never-smoker (excluding atypical/typical carcinoid and small cell tumors)
     • Diagnosed under 50 years of age
     • Have a germline genetic change known/suspected to be linked with increased lung cancer risk
       • ERBB2, EGFR, TP53, STK11, ATM and/or BRCA2
     • Have a strong family history of lung cancer, meaning: one or more individuals had never-smoking lung cancer, one or more individuals were diagnosed with lung cancer before 50, or three or more individuals had lung cancer on one side of the family (regardless of smoking history)
  2. Or, never had lung cancer and no other cancer diagnosis for the past five years, at least 50 years of age or 10 years younger than the first case of lung cancer in the family, and at least one of the following:
     • Have a germline genetic change known/suspected to be linked with increased lung cancer risk
       • ERBB2, EGFR, TP53, STK11, ATM and/or BRCA2
     • Have a strong family history of lung cancer: one or more individuals with never-smoking lung cancer, one or more individuals diagnosed with lung cancer before 50, or three or more individuals with lung cancer on one side of the family (regardless of smoking history)
     • Of East Asian descent with any family history of lung cancer

For more info, email mluong@coh.org

IRB# 21196
AIM 1
Survey patients in the Precision Medicine program to assess the psychosocial response to receiving genomic test results

AIM 2
Survey City of Hope Providers to assess 1) their baseline needs related to genomic care, 2) their self-reported genomic confidence, and 3) their perceptions about the programmatic impact on care

Principal investigator: Stacy W. Gray, M.D., A.M.
Study coordinator: Marilan Luong, mluong@coh.org

Patient Enrollment Qualifications

• Enrolled in INSPIRE or not enrolled on other return of results studies
• Genetic testing ordered or resulted in EPIC Genomics
• English-speaking

For more info, email mluong@coh.org

IRB# 21199: Quantify the longitudinal outcomes of germline testing of patients undergoing paired tumor-normal WES, cancer susceptibility testing, and testing for actionable genetic conditions (e.g., ACMG 59)

Principal investigator: Stacy W. Gray, M.D., A.M.
Study coordinator: Marilan Luong, mluong@coh.org

Patient Enrollment Qualifications

• All participants who consent to INSPIRE and opt to have germline sequencing will be eligible for inclusion in the proposed work.

For more info, email mluong@coh.org

IRB# 22261
AIM 1
Improve rates of family member cascade testing. Hypothesis: Communication of actionable germline results through provider-mediated contact, as compared to patient-mediated contact, will increase cascade testing among patients' first-degree relatives.

AIM 2
Evaluate the psychosocial impact of provider-mediated contact to communicate genetic testing results. Exploratory hypothesis: Patients and family members will have higher levels of satisfaction and lower levels of distress with provider-mediated contact as compared to patient-mediated contact.

Principal investigator: Stacy W. Gray, M.D., A.M., and Heather Hampel, M.S., CGC
Study coordinator: Marilan Luong, mluong@coh.org

Patient Enrollment Qualifications

• Enrolled in IRB# 07047 or have been seen by City of Hope Genetics for genetic testing
• Have a pathogenic or likely pathogenic germline variant
• Fluent in English
• Age ≥ 18 years
• Willing to provide contact information for eligible first-degree relatives
• ≥ One first-degree relative that is eligible for genetic testing and resides in the U.S.

For more info, email mluong@coh.org

IRB# 19432
AIM 1
To develop a patient- and family-focused multi-level intervention, Family First, to facilitate genetic risk communication (patient) and cascade testing (family)

AIM 2
Assess the feasibility and acceptability of using Family First to facilitate family communication

Principal investigator: Stacy W. Gray, M.D., A.M., and Heather Hampel, M.S., CGC
Study coordinator: Marilan Luong, mluong@coh.org

Patient Enrollment Qualifications

The study seeks to enroll English and Spanish-speaking patients seen within the U.S. with a pathogenic or likely pathogenic germline genetic finding and have had their results disclosed.

For more info, email mluong@coh.org

NCT04970056: The purpose of the Pancreatic Cancer Early Detection (PRECEDE) Consortium is to conduct research on multiple aspects of early detection and prevention of pancreatic ductal adenocarcinoma (PDAC) by establishing a multisite cohort of individuals with family history of PDAC and individuals carrying pathogenic/likely pathogenic germline variants (PGVs) in genes linked to PDAC risk for longitudinal follow up. Learn more.

Principal investigator: Gregory E. Idos, M.D., M.S., and James L. Lin, M.D.

Patient Enrollment Qualifications

COHORT 1
Individuals without a history of PDAC (pancreatic ductal adenocarcinoma) meeting any of the following criteria:

• Two+ relatives with PDAC on the same side of the family where two affected are first-degree related to each other and at least one affected is first-degree related to the subject; age 50+ or ≤10 years younger than earliest PDAC in the family at the time of diagnosis
• Two affected first degree relatives with PDAC; age 50+ or 10 years younger than earliest PDAC in family
• BRCA1, BRCA2, PALB2, ATM, MLH1, MSH2, MSH6, PMS2, EPCAM pathogenic or likely pathogenic variant AND one first- or second-degree relative with PDAC; age 50+ or 10 years younger than earliest PDAC in family
• Familial atypical moles and malignant melanoma (FAMMM) with pathogenic or likely pathogenic CDKN2A variant; age 40+
• Peutz-Jegher syndrome with STK11 pathogenic or likely pathogenic variant; age 35+
• Hereditary pancreatitis with PRSS1 pathogenic or likely pathogenic variant and history of pancreatitis; age 40+

COHORT 2
Individuals without a history of PDAC meeting any of the following criteria:

• ATM, BRCA1, BRCA2, or PALB2 pathogenic or likely pathogenic variant regardless of family history, age 50+
• Two+ relatives with PDAC on the same side of the family, any degree of relation, not meeting other criteria above; age 50+ or 10 years younger than earliest PDAC in the family
• One FDR with PDAC ≤ age 45; age up to 10 years younger than PDAC diagnosis in a family member

COHORT 3
The individual meeting criteria for Cohorts 1 or 2 EXCEPT age (e.g., too young to qualify for Cohorts 1 or 2

COHORT 4
Individuals without a history of PDAC presenting for evaluation that do not meet any criteria for 1-3, 6 or the Cyst Cohort

COHORT 5
We may invite individuals without a history of PDAC who are not otherwise engaged in pancreas surveillance at a participating site to participate in the PRECEDE database and to donate biosamples (e.g., blood, saliva and buccal swab) for discovery studies. This may include relatives of individuals in Cohorts 1-4 and 6 and the Cyst Cohort

COHORT 6
Individuals with a personal history of PDAC meeting any of the following criteria:

• Family history includes at least one first-degree relative with PDAC or two relatives with PDAC who are first-degree related to each other
• Personal or family history of a pathogenic or likely pathogenic germline variant in ATM, BRCA1, BRCA2, CDKN2A, EPCAM, MLH1, MSH2, MSH6, PALB2, PMS2, PRSS1 or STK11
• Diagnosed ≤ age 45

CYST COHORT
Individuals with a personal history of a pancreatic cystic neoplasm not meeting any criteria for Cohorts 1-3 or 6 (no known family history of PDAC, no known pathogenic germline variants linked to PDAC risk)

NCT05078866: This phase Ib/II trial evaluates the safety and effect of the Nous-209 vaccine in Lynch syndrome patients. Lynch syndrome is an inherited disorder in which affected individuals have a higher-than-normal chance of developing colorectal cancer and certain other types of cancer, often before age 50. In Lynch syndrome, errors in the genetic information inside cells are not adequately corrected. When that happens, the cells produce new proteins called neoantigens. The body's immune system recognizes neoantigens as foreign, and the body tries to eliminate them. Nous-209 is a vaccine made with artificial copies of some of those neoantigens. This trial aims to see whether the Nous-209 vaccine is safe for patients with Lynch syndrome, whether people can take the Nous-209 vaccine without becoming too uncomfortable, and how the immune system of patients with Lynch syndrome responds to the Nous-209 vaccine. This trial may help researchers determine whether receiving Nous-209 affects the development of polyps or tumors in the colon.

Principal investigator: Gregory E. Idos, M.D., M.S.

Patient Enrollment Qualifications

Participants must have a clinical diagnosis of Lynch syndrome and no evidence of active or recurrent invasive cancer for six months before screening and must be at least six months from any prior cancer-directed treatment. We review additional eligibility criteria when we screen you for participation in the study.

NRG-CC008 and IRB# 23101: To compare the non-inferiority of bilateral salpingectomy (BLS) with delayed oophorectomy to bilateral salpingo-oophorectomy (BSO) to reduce the risk of ovarian cancer among individuals with deleterious BRCA germline mutations

Site principal investigator: Mihae Song, M.D.
Study coordinator: Raechelle Tinsley, rtinsley@coh.org

Patient Enrollment Qualifications

Individuals ≥ 35 and ≤ 50 years of age with BRCA1 mutation

For more info, email clinicaltrialsinfo@coh.org