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topic is Breast cancer 

Cancer Clinical Trials – Cancer Clinical Trial 1

From Spr24_BIOL011_33972

22 unread replies.22 replies.

For this assignment, you will be learning a bit more about a specific type of cancer, as well as how new treatments for cancer are developed. Before beginning, watch this short video about clinical trials:

Post Requirements:

This assignment requires two posts, each completed individually.

First Post – Due Wednesday

Be sure to cite your sources fully, including in-text citations and a full reference list at the end for full credit. 

Write a 3-4 sentence summary describing this type of cancer.

List the risk factors for this type of cancer.

What are two ways that this type of cancer can be prevented?

Use MedGenLinks to an external site. to search for this type of cancer. Click on the first search result. Click on one of the genes associated with this type of cancer.

What is the official full name of this gene?

Read through the summary. What cellular processes and/or functions is this gene involved in? For example, it is important for cell survival? Apoptosis? Microtubule formation?

Use ClinicalTrials.govLinks to an external site. to find a clinical trial that is available for this type of cancer. Enter the name of your cancer, and search for trials within a 200-mile radius of your location. Choose a trial that is recruiting under ‘Study Status’ (see image to the right). Select one of the trials from your search results and answer the following questions: 

Include the title and a link to the clinical trial in your post.

Where is this study being conducted?

What is the study type? Is it interventional, observational, or expanded access? What does this mean?

• What is the intervention or treatment being studied?

What phase is the study in? Explain what this means and its purpose.

What are the eligibility criteria?

1. What is the expected enrollment?
2. Second Post – Due Saturday
3. Choose one classmate’s post to which to respond. Try to respond to someone that hasn’t yet received a response. You will be doing some additional research about the type of cancer your classmate posted about and the clinical trial they shared.
4. To account for the diverse lived experiences and exposures of various populations, clinical trials must be appropriately inclusive of racial and ethnic minority groups, as well as other populations experiencing health disparities, including sexual and gender minority or socioeconomically disadvantaged populations. One way that researchers can work to create representative patient data is to know what “representative” means for the health condition of interest and to set intentional recruitment goals for clinical trials. 

Use United States Cancer StatisticsLinks to an external site. to look up the incidence rates for this type of cancer in the United States in 2020. For which two race/ethnic groups are there the highest incidence rates? For which two groups are there the lowest incidence rates? Embed a screenshotLinks to an external site. of the chart in your post.

In an analysis of clinical trials in the United StatesLinks to an external site. (2020), the FDA found that of the 32,000 participants, 75% were white, 11% were Hispanic, 8% were Black, and 6% were Asian. Given the incidence rates you found for this type of cancer, would a similar demographic breakdown be appropriate for the clinical trial shared by your classmate? Should participation of certain demographic groups be increased/decreased? Explain your reasoning.

Eligibility criteria are necessary for clinical trials to define the patient population under study, isolate the potential effect of an investigational drug, and ensure that the trial is conducted safely. However, excessive or overly rigid eligibility criteria may impair the rate of trial accrual, restrict patient access to investigational drugs, and limit the ability to generalize the results to the broader population of patients who will ultimately have access to the treatment.

Look at the exclusion criteria for the clinical trial shared by your classmate. Are any of the following groups excluded?

Children (<13 years old)

The elderly (>65 years old)

Pregnant women

1. Lactating women
2. People with chronic diseases (heart disease, hypertension, diabetes, etc.)
3. What implications do these exclusions have for the generalizability of the results of this clinical trial?

List two questions that someone might have about participating in this clinical trial.

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