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Clinical Trials and Gynecologic Cancer

★ Why And When To Enter A Clinical Trial?

For gynecologic cancer patients, clinical trials can be an option at the beginning of treatment as well as later on in the event of recurrence. It is worth noting that many clinical trial protocols limit the number of rounds and types of chemotherapy previously taken.

 

Clinical trials or clinical research studies involve testing the effectiveness of new drugs for cancer (and other illnesses) on human subjects.

 

Participating in a clinical trial helps to further the field of cancer treatment and provides patients the opportunity to try medications that might be effective against their disease.

 

University of Colorado Cancer Center
Colorado’s only National Cancer Institute (NCI)-Designated Cancer Center
Phone: 720.848.0300


“The University of Colorado Cancer Center in Denver is one of just 45 elite Comprehensive Cancer Centers in the entire country and the only one in Colorado. We're known worldwide for developing and setting new standards in the treatment of many types of cancer. Our 5-year cancer outcomes far outpace state averages as well as those of many other cancer centers in the U.S.”


https://www.cancer.gov/research/nci-role/cancer-centers/find/ucolorado

 

 

To find Clinical Trials currently being offered at CU Cancer Center:
Overview of the CU Cancer Center: http://www.ucdenver.edu/academics/colleges/medicalschool/centers/cancercenter/clinicaltrials/Pages/ClinicalTrials.aspx

Cancer Clinical Trials Office at the CU Cancer Center: https://medschool.cuanschutz.edu/colorado-cancer-center/clinical-trials/ccto-team

 

Current Ovarian Cancer Studies at the CU Cancer Center: https://researchstudies.cuanschutz.edu/Search/Results?type=text&Search=ovarian&Search=

Sarah Cannon Research Institutes
asksarah@sarahcannon.com

303.253.3225


“Sarah Cannon and the HealthONE Family of Hospitals in Denver, Colo. are fighting cancer together to offer patients cutting-edge clinical research alongside integrated cancer services from discovery to recovery. “


Red Rocks Cancer Center - 303-945-2960


Swedish Medical Center - 303-788-5000


https://sarahcannon.com/locations/

“askSarah” has a 24/7 line staffed by nurses: 844-482-4812

 

ClinicalTrials.gov

“ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world." (It is important to note that the U.S. government does not review or approve the safety of all studies listed on the website.)

https://clinicaltrials.gov/

 

U. S. National Institutes of Health  (NIH)

“The goal of clinical trials is to determine if a new test or treatment works and is safe. Clinical trials can also look at other aspects of care, such as improving the quality of life for people with chronic illnesses.” Information about clinical trials can be found at:

https://www.nih.gov/health-information/nih-clinical-research-trials-you

 

EmergingMed Navigator

“EmergingMed’s Clinical Trial Navigators provide concierge support to patients and physicians searching for clinical trial opportunities that match a patient’s specific diagnosis, symptoms or stage, and treatment history.”

 

Home page here

Match for trials here

Request a contact here

The Clearity Foundation

“The Clearity foundation is committed to science, devoted to patients, Clearity is your trusted partner for the ovarian cancer journey.”

https://forms.clearityfoundation.org/find-clinical-trials/

★ Clinical trial drugs are paid for by the research study, and Colorado law requires insurance to cover routine patient care costs in clinical trials. Check with your insurer about any additional costs of required scans and blood tests.

 

COCA may help pay for transportation to a clinical trial. Visit COCACares on our Financial Assistance Program page of our website. 

 

Clinical Trial Phases

Phase:  The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.

Early Phase 1 (formerly listed as Phase 0) - studies conducted before traditional phase 1 trials to investigate if and how a drug affects the body. They involve very limited human exposure to the drug, and have no therapeutic or diagnostic goals. Some examples are screening studies or microdose studies.

Phase 1 - A phase of research to describe clinical trials that focus on the safety of a drug. They are usually conducted with healthy volunteers, and the goal is to determine the drug's most frequent and serious adverse events and, often, how the drug is broken down and excreted by the body. These trials usually involve a small number of participants.

 

Phase 2 - A phase of research to describe clinical trials that gather preliminary data on whether a drug works in people who have a certain condition/disease (that is, the drug's effectiveness). For example, participants receiving the drug may be compared to similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied.

 

Phase 3 - A phase of research to describe clinical trials that gather more information about a drug's safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. These studies typically involve more participants.

 

Phase 4 - A phase of research to describe clinical trials occurring after FDA has approved a drug for marketing. They include postmarket requirement and commitment studies that are required of or agreed to by the study sponsor. These trials gather additional information about a drug's safety, efficacy, or optimal use.

Phase Not Applicable - Describes trials without FDA-defined phases, including trials of devices or behavioral interventions.

For more information on clinical trials, please visit this website: https://clinicaltrials.gov/study-basics/glossary

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