Genetic Study of RRP

Frequently Asked Questions and Explanations

Table of Contents

  1. What is the difference between consent forms and assent forms and what do I need to sign?
  2. Is the study only about Juvenile-Onset RRP (JORRP)?
  3. Are you still interested if the RRP is in remission?
  4. I do not live in the United States of America. Can I still participate?
  5. Are there any age limits?
  6. What about all my other relatives? They are all willing to enroll and would like to help.
  7. Will we be told the results when the study has been completed?
  8. Has this got anything to do with my Otolaryngologist (Ear, Nose and Throat Surgeon)?
  9. What information will you need before you can enroll me?

What is the difference between consent forms and assent forms and what do I need to sign?

Consent forms are used to document that you have been informed about the study and that you wish to participate. One of these forms has to be signed for each separate human who is participating. The person who signs it must be an adult (18 years or older). If the person named on the consent form is not an adult then one of the child's parents or legal guardians need to sign on the child's behalf.

Assent forms are written so that a child can understand them. Assents are meant to be signed by a child participating in the study

bulletDownload consent form
bulletGo see all the forms
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Is the study only about Juvenile-Onset RRP (JORRP)?

No. We are enrolling people with Adult-Onset RRP as well.

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Are you still interested if the RRP is in remission?

Yes. You have the same genes now as you had when you or your child had active RRP therefore studying the genetics of the patient in remission as well as their biologic parents helps us to discover which genes are involved.

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I do not live in the United States of America. Can I still participate?

Yes. We will mail the tubes of mouthwash and the questionnaire to you. We will provide you with a Federal Express pre-paid international waybill that you can use to ship the kit back to us.

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Are there any age limits?

No. There are no age limits per se. However, children who have not yet acquired the ability to swish and spit (rather than swallow) will be excluded from this part of the study. Even if your child is too young to participate, we would love to hear from you. We can record your details and contact you yearly and enroll you once your child has developed to the point that they can swish and spit ScopeŽ mouthwash. Alternatively, you could tell us who the treating otolaryngologist is and where your child usually undergoes surgery. We would contact the otolaryngologist and invite him or her to join the multi-center study that is running parallel to this support-group study.

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What about all my other relatives? They are all willing to enroll and would like to help.

We are heartened by the enthusiasm of so many people but the design of the genetic analysis means that cousins and the children of patients can not help us discover what we are looking for. We are only seeking the genetic material of the patient, his or her mother and his or her father. Only if one or both of the parents are available would we want to enroll the patient's siblings if they share the missing parent. If you have any questions or think that your situation may be unusual then please feel free to contact Dr. Buchinsky.

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Will we be told the results when the study has been completed?

In a general sense "yes" but in a specific sense "no." When we find a genetic susceptibility for RRP we will publish it in the scientific literature and we will disseminate the news through the patient support groups. However, we in the Center for Genomic Sciences will not contact individual people to inform them of their genetic status as it relates to RRP. Our RRP research is not set up as a clinical service for individual patients; such services are governed by an extensive set of regulations that do not permit us to provide specific individual information.

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Has this got anything to do with my Otolaryngologist (Ear, Nose and Throat Surgeon)?

No...However, participants are being enrolled in the study by two different methods. Let us call the first design "Satellite Desgin" and the other "Support-group Design."

The "Satellite design" was established in 2002. Individual surgeons choose to collaborate with Dr. Buchinsky. The collaborating surgeon seeks approval from his or her hospital's Institutional Review Board. Once that has been granted the collaborating surgeon informs his or her patients about the study and offers to enrol them. If they are agreeable, a blood specimen and a papilloma specimen is obtained from the patient the next time they undergo anesthesia. At the same visit, blood is obtained from the patient's mother and father. The specimens as well as some clinical information are then sent by by the surgeon from the satellite site to Dr. Buchinsky at the coordinating center.

The "Support-group design" was established in 2005 to supplement the "Satellite design" but not to replace it. Instead of being invited by one's surgeon, the support groups and its members publicized the existence of the study. Patients or their parents are invited to contact Dr. Buchinsky or Ms. Smith (research coordinator) directly. A kit containing ScopeŽ mouthwash, consent forms and a questionnaire are sent to the participant's home. Once completed the participant sends the kit back in a prepaid envelope to the coordinating center in Pittsburgh, PA.

Click on figure to see diagram (but please be patient)

  Satellite Design Support-Group Design
DNA (genetic material) obtained from blood mouthwash
Amount of genetic material obtained "tons" with enough to do many different analyses, repeatedly if necessary small amount but enough to do analysis
Specimen obtained in hospital or doctor's office in participant's home
Papilloma specimen obtained during anesthesia no papilloma specimen
Regulatory oversight IRB of each hospital IRB of the Allegheny-Singer Research Institute
Your primary contact person Your otolaryngologist who treats you Dr. Buchinsky or Ms. Smith in Pittsburgh, PA
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What information will you need before you can enroll me?

When you initially contact us please tell us the following information so that we can send the appropriate materials to you.

  1. Name of patient who has RRP.
  2. Age of patient now. If he or she is less than 6 years old, then does the child know how to swish and spit.
  3. Age of patient at diagnosis, since we need to know if the RRP was juvenile-onset or adult-onset. We have a different questionnaire for each.
  4. Is the patient's mother willing to participate? Does she live with patient? (We need to know where to send the kit)
  5. Is the patient's father willing to participate? Does he live with patient?
  6. If either the mother or the father are not available then are full siblings available? How old are they and where do they live?
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Farrel J. Buchinsky.
Revised: 03/08/06.

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