A Phase 1 interventional study of Biospecimen Collection and Genetic Counseling in Breast Carcinoma, Digestive System Neoplasm and Malignant Brain Neoplasm, sponsored by Mayo Clinic. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-24.
Sponsored by Mayo Clinic · Phase 1, Interventional, and Prevention
This phase I trial collects blood samples to investigate the prevalence of changes in genes (genetic mutations) in solid tumor patient populations seeking care at Mayo Clinic Embedded Cancer Center at St. Vincent's Riverside. This may help doctors better understand and/or treat others who have genetic mutations.
PRIMARY OBJECTIVE:
I. To determine the prevalence of genetic mutations in cancer patients seeking care at the Mayo Clinic Cancer Center at St. Vincent's Riverside in Jacksonville, Florida.
SECONDARY OBJECTIVES:
I. Perform a chart review to assess the impact of genetic testing as part of standard of oncology care:
Ia. Determine differences in germline mutation detection in these patients as compared to traditional guideline (National Comprehensive Cancer Network [NCCN]) based approach for genetic evaluation.
Ib. Determine the percentage of relatives of mutation positive probands undergoing family variant testing within a 3 month window of return of testing results.
Ic. Assess patient experience and barriers to care with a genetic service line via survey measures.
Id. Develop a biorepository of samples (blood) from cancer patients participating in this protocol.
OUTLINE:
Patients watch a pre-recorded genetic counseling video and those who consent to genetic testing undergo collection of blood samples. Patients also complete surveys over 5-15 minutes each prior to receiving their genetic test results and following the receipt of genetic test results.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's enrollment of 230 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.
Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients watch a pre-recorded genetic counseling video and those who consent to genetic testing undergo collection of blood samples. Patients also complete surveys over 5-15 minutes each prior to receiving their genetic test results and following the receipt of genetic test results.
Procedure: Biospecimen Collection · Other: Genetic Counseling · Other: Genetic Testing · Other: Survey Administration
Undergo collection of blood samples
Watch pre-test genetic counseling video
Undergo genetic testing
Also known as: genetic analysis, Genetic Examination, Genetic Test
Ancillary studies
Prevalence of pathogenic germline mutations
Will be assessed by each cancer site, age (\< 60 years old versus \[vs.\] \>= 60 years old), and stage (early vs. advanced) via descriptive statistics.
Time frame: Up to 3 months
Difference between prevalence of positive pathogenic germline mutations
Will be assessed by cancer sites, age of diagnosis, and stage of diagnosis using logistic regression analysis across all cancer site groups, and pairwise post-hoc analyses using Tukey's correction for multiple comparisons across pairs of cancer sites, and chi-square tests of differences between age and stage groups.
Time frame: Up to 3 months
Rate of mutation detection
Will be compared via genetic testing to clinical practice guidelines of traditional family history criteria within cancer site, age, and stage using logistic regression and pairwise post-hoc analyses as needed.
Time frame: Up to 3 months
Incidence rate of germline pathogenic genetic mutations in cancer patients seen at St Vincent's and uptake rate of cascade testing in families
Assessed using logistic regression
Time frame: Up to 3 months
Incidence rate of germline pathogenic genetic mutations in cancer patients seen at St Vincent's and uptake rate of cascade testing in families
Assessed using pairwise post-hoc analyses
Time frame: Up to 3 months
Differences in survey responses between patient groups
Patients will be grouped by genetic test result (positive vs. negative), age (\< 60 years old vs. \>= 60 years old), stage (early vs. advanced), and over time (enrollment vs. after test results are received).
Time frame: Up to 3 months
Ran from Jun 2020 to primary completion in Sep 2021, 14 months.
Of 371 non-industry phase 1 interventional studies under Breast Neoplasms, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 77. This study's 14 months is below that.
Counting every sponsor, half of 759 studies reached it within 44 months; a quarter within 25 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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