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Protocol Details

Evaluation of Efficacy & Immune-Related Adverse Events and Patient-Reported Symptoms Associated with Immunotherapies: MD Anderson Cancer Center Efforts for Advanced Mechanistic, Clinical and Translational Science

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

001948-C

Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Recruitment has not started
Gender: Male & Female
Min Age: 18 Years
Max Age: 120 Years

Referral Letter Required

No

Population Exclusion(s)

Non-English Speaking;
Children;
Fetuses;
Pregnant Women;
Neonates

Keywords

Questionnaire;
Side Effects;
Toxicity

Recruitment Keyword(s)

None

Condition(s)

Malignant Neoplasms;
Carcinoma

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

Other: Patient Reported Outcomes (PROs)

Supporting Site

National Cancer Institute

Background:

Many newer cancer treatments use immunotherapy. That is, agents are given to cause the immune system to fight cancer cells. But some people who have had these treatments get bad side effects. They may develop issues in the skin, liver, and other organs. Researchers want to learn more about how immunotherapies may affect people with cancer.

Objective:

To monitor side effects in people with cancer who are treated with immunotherapies.

Eligibility:

People aged 18 years and older with cancer. They must be either (1) starting immunotherapy; or (2) having immune-related side effects while receiving immunotherapy.

Design:

Participants medical records will be reviewed.

Participants will undergo their prescribed cancer treatments. They will be watched for side effects. They will have blood drawn just for research.

Participants will fill out questionnaires once a week for the first 9 weeks of their treatment. They will answer questions about their general health and how they are feeling. These questionnaires can be done on a website or on paper. Each takes about 15 minutes.

From week 9 to week 13, participants will fill out questionnaires only when their tumors are imaged.

Participants will have a follow-up visit 30 days after their treatment ends. They may continue having follow-up visits to watch for long-term effects of immunotherapy; these visits may be by a clinic visit or a phone call.

Sponsoring Institution: MD Anderson Cancer Center

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Eligibility

INCLUSION CRITERIA:

-Patients must be able to understand and be willing to sign a written informed consent document.

-Patients must be under consideration or currently enrolled for any regimen that includes an immunotherapeutic agent (monotherapy or combination therapy).


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

James L. Gulley, M.D.
National Cancer Institute (NCI)
NIHBC 10 - CLINICAL CENTER BG RM 13N240C
10 CENTER DR
BETHESDA MD 20892
(301) 480-7164
gulleyj@mail.nih.gov

NCI Medical Oncology Referral Office
National Cancer Institute (NCI)

(240) 760-6050
ncimo_referrals@nih.gov

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
1-888-NCI-1937
ncimo_referrals@mail.nih.gov

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