Prospective Data Collection of Patients Treated With Proton Therapy for Head and Neck Malignancies
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/16/2018 |
| Start Date: | January 2012 |
| End Date: | January 2019 |
| Contact: | Steven J. Frank, MD |
| Phone: | 713-563-2361 |
The goal of this data review research study is to collect medical record information from
patients with head and neck cancer that have received or are scheduled to receive proton
therapy at MD Anderson. Researchers will study the medical record information to try and
improve therapy for future patients with head and neck cancer.
This is an investigational study.
Up to 450 participants will take part in this study. All will be enrolled at MD Anderson.
patients with head and neck cancer that have received or are scheduled to receive proton
therapy at MD Anderson. Researchers will study the medical record information to try and
improve therapy for future patients with head and neck cancer.
This is an investigational study.
Up to 450 participants will take part in this study. All will be enrolled at MD Anderson.
If you agree to take part in this study, information will be collected from your medical
records that is related to your personal medical history, diagnosis, and the treatment you
received or are scheduled to receive for head and neck cancer. The information from your
medical record will be collected at least 1 time, however, the study doctor may collect
additional information from your medical records at any time in the future for the purposes
of this study.
You will complete 5 questionnaires before your treatment begins, at each visit during your
treatment, and again at all follow-up visits related to your treatment. It should take about
30 minutes to complete the questionnaires each time. The questionnaires may be performed in
person by mail, by phone or by secure electronic methods. The research coordinator will
notify you via telephone, mail or via electronic notification approximately 2-3 weeks after
the questionnaire is sent to remind you and also give you the option of performing the survey
by other means.
All information that is collected for this study will be stored in a password-protected
computer and database at MD Anderson for use in future research related to cancer.
Your medical record information will be given a code number. No identifying information will
be directly linked to your medical record information. Only the researcher in charge of the
password-protected computer and database will have access to the code numbers and be able to
link your medical record information back to you. This is to allow medical data related to
your medical record information to be updated as needed. Other researchers using your medical
record information from the password-protected computer and database will not be able to link
any information back to you.
Length of Study:
After you sign this consent form, your active participation in this study will be over. Your
medical record information may be collected indefinitely.
records that is related to your personal medical history, diagnosis, and the treatment you
received or are scheduled to receive for head and neck cancer. The information from your
medical record will be collected at least 1 time, however, the study doctor may collect
additional information from your medical records at any time in the future for the purposes
of this study.
You will complete 5 questionnaires before your treatment begins, at each visit during your
treatment, and again at all follow-up visits related to your treatment. It should take about
30 minutes to complete the questionnaires each time. The questionnaires may be performed in
person by mail, by phone or by secure electronic methods. The research coordinator will
notify you via telephone, mail or via electronic notification approximately 2-3 weeks after
the questionnaire is sent to remind you and also give you the option of performing the survey
by other means.
All information that is collected for this study will be stored in a password-protected
computer and database at MD Anderson for use in future research related to cancer.
Your medical record information will be given a code number. No identifying information will
be directly linked to your medical record information. Only the researcher in charge of the
password-protected computer and database will have access to the code numbers and be able to
link your medical record information back to you. This is to allow medical data related to
your medical record information to be updated as needed. Other researchers using your medical
record information from the password-protected computer and database will not be able to link
any information back to you.
Length of Study:
After you sign this consent form, your active participation in this study will be over. Your
medical record information may be collected indefinitely.
Inclusion Criteria:
1. Retrospective chart analysis will be performed on all patients documented to have head
and neck cancer treated with Proton Therapy at MDACC from January 1, 2008 through April 30,
2012. We will prospectively consent patients who receive treatment from May 1, 2012 through
December 31, 2017. Patient charts will be reviewed to determine pretreatment
characteristics, time to progression and overall survival of patients.
Exclusion Criteria:
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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