"Heritable
and Sporadic Genetic Lesions in Canine Lymphoma and Osteosarcoma"
*
Participants Need for Research On Canine Cancer *
FORM: 'Informed Consent of Participants'
For
more information, contact the Principal Investigator, Dr. Jaime Modiano at
303-239-3408 or 303-239-3587.
THE
STUDY
The
research project “Heritable and Sporadic Genetic Lesions in Canine Lymphoma and
Osteosarcoma” is part of Dr. Jaime Modiano’s laboratory program “Genetics
of Canine Cancer”. This
program is part of a collaborative effort between Dr. Modiano at the AMC Cancer
Research Center in Denver, CO and Dr. Matthew Breen at North Carolina State
University in Raleigh, NC; it is supported by the American Kennel Club Canine
Health Foundation (AKC CHF Grant 2254) and by the Rottweiler Health Foundation.
The purpose of the project is to determine how genes impact the
development of cancer in dogs. Specifically, the researchers will study abnormalities in
genes and chromosomes in canine
lymphoma (cancer of white blood cells in the lymph glands) and
osteosarcoma (bone cancer), to determine if
these abnormalities are inherited, and to assess their clinical significance
(that is, if they are predictive regarding response to treatment and prognosis).
PARTICIPANT
REQUIREMENTS
Golden Retrievers, Rottweilers, and Mastiffs
with known pedigrees can participate in this study.
Dogs from other breeds require prior approval from one of the
investigators. The affected dog(s)
can be male or female (intact or neutered), and must be between 4 months and 12
years old, in otherwise good enough health to tolerate diagnostic procedures
(radiographs, blood draw, and biopsy), and treatment.
Dogs must have a diagnosis of multicentric lymphoma (stage II - IV), or
appendicular stage I or II osteosarcoma (no evidence of metastatic disease) from
a licensed veterinarian. There must
be at least two unaffected first-degree relatives (parents, siblings, or
offspring) of the affected dog that will consent to participate (through
donation of >10 ml of EDTA-anticoagulated blood).
Owners of affected dogs will sign informed consent forms authorizing
pre-treatment excisional biopsies, and committing to treat the affected dog with
an acceptable protocol (e.g., the “Wisconsin” protocol for multicentric
lymphoma or limb amputation and systemic chemotherapy for appendicular
osteosarcoma) at least until it can be determined if remission is achievable.
Dogs who have been previously treated are not eligible for the study.
PROCEDURES
Enrollment
will open on or about June of 2002 and continue until December of 2004.
Participation in this study will include the regular admission and
discharge procedures to a Veterinary Referral Hospital.
Materials for this study (blood and tumor samples) will be obtained
during the normal procedures for diagnosis and treatment of cancer that are
requested and approved by the owner of the dog.
The following steps must be followed precisely to facilitate enrolment
and proper treatment of samples:
The
owner and/or attending veterinarian must contact Dr. Jaime Modiano at the AMC
Cancer Research Center in Denver at least 24 hours prior to surgery or biopsy
procedures. No participants can be enrolled without prior approval from
one of the investigators.
The
owners of the affected dog must read and sign an informed consent form
(available from Dr. Modiano), and must submit a copy of the dog’s pedigree.
Contact
information for at least two individuals who own first-degree relatives
(parents, sibs, offspring) of the affected dog who will be willing to
participate in the study must be provided.
Dr.
Modiano’s laboratory personnel will send special shipping media, materials,
and pertinent instructions by overnight courier to the attending veterinarian.
A
viable tumor sample must be obtained using aseptic technique (surgery or biopsy)
by a licensed veterinarian. This
sample must be placed into the sterile containers containing the shipping media
and returned to Dr. Modiano’s laboratory by overnight courier.
Samples are generally not received on Saturdays or Sundays.
Since samples will undergo degradation upon prolonged storage, we request
that procedures performed on Fridays be avoided, whenever possible.
A
blood sample (10 - 15 ml) must also be submitted in EDTA (“purple-top”
tubes) in an appropriate shipping container.
For
additional information contact Dr. Modiano at 303-239-3408 or at modianoj@amc.org.
Information and updates will also be posted on the AMC Cancer Research
Center web site (www.amc.org).
COMPENSATION
FOR PARTICIPATION AND FOR THERAPY OR INJURIES
The study will not provide compensation or treatment for any accidental injury
that may occur while a dog is a participant.
Participation in this research
project will help defray charges incurred for the diagnostic procedures through
which samples for the study will be obtained:
The
study will provide $250 for each affected participant to defray portions of the
costs associated with the biopsy procedures.
Formalin-fixed samples or samples submitted in any fashion other than
that described above are unsuitable for the study and cannot be accepted.
The
study will pay for shipping costs and for histopathology/immunohistology tests.
Results will be sent by fax to the attending veterinarian.
INSTRUCTIONS
TO VETERINARIANS
Blood
samples and tumor tissue will need to be submitted at the time of diagnosis.
For all cases, it also will be necessary to obtain tissues at the time of
death or necropsy.
Histopathology
support will be provided exclusively by IDEXX laboratories in Broomfield, CO. Special tests may be performed by IHC Services in Smithville,
TX, or other commercial or academic laboratories at the discretion of the
investigators. Any information that
has diagnostic relevance will be communicated to the referring veterinarian in a
timely manner.
Owners
of unaffected sibs or first degree relatives must be contacted to arrange for
donation of blood for each participant recruited.
Veterinarians
must contact the Principal Investigator ahead of time to arrange FedEx or other
billing associated with sample submission.
We
will require follow-up information on each patient, including specific treatment
protocol, time to remission, disease-free interval, condition and time of
relapse (if applicable), survival time, and cause of death.
We will make every effort to contact you regularly to obtain information
on this patient, or you can fax updates from the medical record to Dr. Modiano
at 303-239-3560.
For
more information, contact the Principal Investigator, Dr. Jaime Modiano at
303-239-3408 or 303-239-3587.
SPECIFIC
INSTRUCTIONS FOR SAMPLE SUBMISSION
Peripheral
blood samples:
two to three EDTA tubes (5 ml each) shipped at room temperature.
Samples can be shipped by regular mail.
If blood is shipped with additional samples in formalin, please isolate
the blood tubes in a sealed, impermeable (e.g., Ziplock) bag.
Tumor
samples:
we require fresh, sterile, viable tissues for this study.
It is imperative that tissues be obtained from viable areas, as necrosis
will hinder our ability to use the samples.
Sterile, viable tissue allow for the establishment of immortalized cell
lines that can be used in the laboratory for years to come to study the
processes that lead to cancer, as well as to develop novel therapies.
A large enough sample of viable tissue allows the investigators to
allocate a suitable sample for fixation and histopathology, so it is not
necessary to submit fixed tissues.
Collection
of viable tissue requires exceptional attention to detail and aseptic technique.
The excised, sterile tumor must be placed in a sterile container with a
sterile support medium (provided by the investigators as tissue culture media
with antibiotics). If the tumor
sample is too large to fit in the container (conical tube) provided, it can be
cut into smaller sections using sterile instruments while the tumor is placed on
a sterile surface (for example, a sterile sponge or the surgical drape).
The tissue must never contact a non-sterile surface (for example, the
operating table or the instrument table). Sterile
saline (0.9% NaCl) is unacceptable as transport media because the lack of a pH
buffer makes the solution acidify rapidly, diminishing the viability of the
tissue.
The
container (tube or tubes) with the sterile tumor sample should be placed on ice
(a suitable ice pack for shipping) immediately and shipped overnight via Federal
Express, observing all regulations for shipping of viable tissues. The Principal Investigator has a dedicated account at AMC
Cancer Research Center to cover shipping costs. Please contact for instructions.
Also, please contact the Principal Investigator in advance to arrange
sample processing immediately on arrival.
Please
note: eligibility criteria require submission of viable tissues for
participation.
For
more information, contact the Principal Investigator, Dr. Jaime Modiano at
303-239-3408 or 303-239-3587.