Current Research Opportunities at UCSF
Clinical research is aimed at finding better ways to prevent and treat disease. Research is an important tool for improving health care and treatment of people around the world. Whether or not you want to participate in research is your choice and there are protections in place for individuals who chose to participate in clinical research studies. Clinical research is regulated by the federal government and each study has an institutional review board (IRB) and Human Subjects Research Protection Program to protect the safety and privacy of participants.
A clinical trial is a study that evaluates the safety and effectiveness of a new approach to detecting, preventing, diagnosing or treating a disease. Clinical trials are how researchers determine whether the new approach is better than current ones. When conducting a clinical trial, researchers must follow strict rules to protect the participants. To learn more about clinical trial at UCSF, you can read more by clicking here. Observational studies are a different type of research that aim to identify and study patterns in medical data provided by study participants. Below are some potential research opportunities available at UCSF for individuals with Lynch syndrome.
Lynch Vaccine Trial
The National Institutes of Health (NIH) / National Cancer Institute is sponsoring a Mult-institutional study to evaluate the effectiveness of a vaccine to lower risk of colon cancers in Lynch syndrome.
Because people with Lynch syndrome often develop colon polyps that can progress to colon cancer, the thought is if the immune system can be trained to detect and destroy early polyps the risk of cancer will be lowered. The goal of this study is to assess the safety and effectiveness of the three vaccines (Tri-Ad5), combined with a protein (N-803) that will boost the vaccines’ effects, to see if there is an effect on the risk of developing colon and other cancers in patients with Lynch syndrome.
To be eligible for the study you must:
- Have been diagnosed with Lynch syndrome.
- Be age 18 years old or older.
- Have not had any cancer treatment in the past 6 months.
- Have past history of adenoma (a type of colon polyp) or colon cancer (but now cured)
Participants will be asked to do the following:
- Receive 4 injections four times over a one-year period.
- Attend study appointments.
- Donate blood samples and complete a physical exam.
- Complete your planned colonoscopies annually at the trial site (UCSF).
Principal Investigator at UCSF: Aparajita Singh MD
Research Coordinator: Rachael Leigh Delacruz
For any questions, please contact: [email protected]
More information: https://clinicaltrials.gov/study/NCT05419011
PRECEDE Consortium
Individuals with Lynch syndrome can participate in PRECEDE consortium. The Pancreatic Cancer Early Detection (PRECEDE) Consortium is an international, multi-institutional study to increase survival for pancreatic cancer patients by improving early detection, screening, and prevention. Any Lynch Syndrome patient can participate in this study. Being part of the study involves collection of your medical records, blood/ saliva/ stool sample. Your medical care is done according to your risk by your providers.
People who have any of the following can consider participating in PRECEDE:
- Be age 18 years old or older.
- Have a personal and/or family history of pancreatic cancer
- Have a gene change that causes higher risk for pancreatic cancer found through genetic testing
- Have a certain types of pancreatic cysts
Participants will be asked to do the following:
- Provide an annual sample of blood
- Provide a one-time DNA sample
- Provide medical and family medical history
- Provide permission to access your medical records to include information in the PRECEDE database, including results from your regular medical care, genetic testing, and imaging (MRI/MRCP, EUS, CT scan)
- If you are diagnosed with pancreatic cancer, you may be asked to donate extra tissue at the time of biopsy or surgery
Principal Investigator at UCSF: Margaret Tempero, MD
For any questions, please contact: [email protected]
More information: https://precedestudy.org/ and https://clinicaltrials.gov/study/NCT04970056