Laboratory Assay in Determining Cancer Resistance in Patients With Metastatic Cancer and in Healthy Participants
Official Title
Pilot Study of Cancer Resistance in Humans
Acronym
Not provided
Organization
Wake Forest University Health SciencesOTHER
Status Module
Record Verification Date
Apr 2017
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Sep 2005Actual
Primary Completion Date
Oct 23, 2009Actual
Completion Date
Oct 23, 2009Actual
First Submitted Date
May 9, 2009
First Submission Date that Met QC Criteria
May 9, 2009
First Posted Date
May 12, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
May 25, 2017
Last Update Posted Date
May 30, 2017Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Wake Forest University Health SciencesOTHER
Collaborators
Name
Class
National Cancer Institute (NCI)
NIH
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
No
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
RATIONALE: Studying samples of blood and tissue in the laboratory from patients with cancer and from healthy participants may help doctors learn more about cancer.
PURPOSE: This laboratory study is looking at an assay in determining cancer resistance in patients with metastatic cancer and in healthy participants.
Detailed Description
OBJECTIVES:
Optimize and standardize the in vitro cell kill assay using human white blood cells and human cancer cell lines from patients with metastatic cancer and from healthy participants.
Determine the results of the in vitro cell kill assay in patients with metastatic cancer and in healthy participants with no history of cancer.
OUTLINE: This is a pilot study.
Peripheral blood is obtained from healthy participants and from cancer patients. Tissue is collected from archived samples. White blood cells are obtained from tissue and blood samples and are assessed by the in vitro cell kill assay.
PROJECTED ACCRUAL: A total of 24 patients and 24 healthy participants will be accrued for this study.
Conditions Module
Conditions
Cancer
Keywords
stage IV bladder cancer
stage IV colon cancer
stage IV non-small cell lung cancer
stage IV pancreatic cancer
stage IV rectal cancer
stage IV renal cell cancer
stage IV melanoma
stage III multiple myeloma
extensive stage small cell lung cancer
stage IV adult soft tissue sarcoma
stage III malignant testicular germ cell tumor
stage IV breast cancer
stage IV ovarian epithelial cancer
stage IV prostate cancer
stage IV endometrial carcinoma
unspecified adult solid tumor, protocol specific
metastatic osteosarcoma
stage IV uterine sarcoma
stage III ovarian epithelial cancer
Design Module
Study Type
Observational
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
No
Target Follow-Up Duration
Not provided
Phases
Not provided
Interventional Study Design
Allocation
Not provided
Intervention Model
Biospecimen
No data available
No data is available for this block.
Enrollment
54Actual
Arms/Interventions Module
Arm Groups
Not provided
Interventions
Name
Type
Description
Arm Group Labels
Other Names
immunological diagnostic method
Other
physiologic testing
Other
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Cell killing ability (positive or negative)
Day 180
Percentage of cells killed
Day 180
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
-Meets 1 of the following criteria:
Diagnosis of metastatic cancer including, but not limited to, any of the following:
Stage IV non-small cell lung cancer
Extensive-stage small cell lung cancer
Metastatic testicular cancer
Stage IV breast carcinoma
Stage III or IV ovarian carcinoma
Stage IV endometrial carcinoma
Stage IV prostate carcinoma
Stage IV colorectal or pancreatic cancer
Stage IV renal cancer
Stage III or IV non-Hodgkin's lymphoma
Stage IV bladder cancer
Stage III multiple myeloma (Salmon-Durie staging)
Metastatic melanoma
Metastatic sarcoma
Healthy participant, meeting the following criteria:
No prior cancer
Over 50 years of age
Exclusion Criteria:
Serious medical or psychiatric condition that would preclude study compliance
Chemotherapy or radiotherapy within the past 3 months (patient)
Prior immunosuppressive therapy or radiotherapy for any disease (healthy participant)
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
Not provided
Maximum Age
120 Years
Standard Ages
ChildAdultOlder Adult
Study Population
Those with metastatic cancer OR healthy individuals with no prior cancer diagnosis and who are over the age of 50.
Sampling Method
Non-Probability Sample
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Zheng Cui, PhD
Wake Forest University Health Sciences
Study Chair
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Wake Forest University Comprehensive Cancer Center
Winston-Salem
North Carolina
27157-1096
United States
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
ID
Term
D009369
Neoplasms
D001749
Urinary Bladder Neoplasms
D003110
Colonic Neoplasms
D002289
Carcinoma, Non-Small-Cell Lung
D010190
Pancreatic Neoplasms
D012004
Rectal Neoplasms
D002292
Carcinoma, Renal Cell
D008545
Melanoma
D009101
Multiple Myeloma
D012509
Sarcoma
D013736
Testicular Neoplasms
D001943
Breast Neoplasms
D000077216
Carcinoma, Ovarian Epithelial
D011471
Prostatic Neoplasms
D016889
Endometrial Neoplasms
D012516
Osteosarcoma
D002051
Burkitt Lymphoma
D016403
Lymphoma, Large B-Cell, Diffuse
Ancestor Terms
ID
Term
D014571
Urologic Neoplasms
D014565
Urogenital Neoplasms
D009371
Neoplasms by Site
D052776
Female Urogenital Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
Intervention Browse Module
No data available
No data is available for this block.
ovarian sarcoma
stage IV adult Burkitt lymphoma
stage III adult diffuse large cell lymphoma
stage III adult diffuse mixed cell lymphoma
stage III adult diffuse small cleaved cell lymphoma
stage IV adult diffuse large cell lymphoma
stage IV adult diffuse mixed cell lymphoma
stage IV adult diffuse small cleaved cell lymphoma
stage III adult Burkitt lymphoma
stage III adult immunoblastic large cell lymphoma
stage IV adult immunoblastic large cell lymphoma
stage III adult lymphoblastic lymphoma
stage IV adult lymphoblastic lymphoma
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
stage IV grade 3 follicular lymphoma
stage III mantle cell lymphoma
stage IV mantle cell lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
nodal marginal zone B-cell lymphoma
splenic marginal zone lymphoma
stage III marginal zone lymphoma
stage IV marginal zone lymphoma
stage III small lymphocytic lymphoma
stage IV small lymphocytic lymphoma
stage III mycosis fungoides/Sezary syndrome
stage IV mycosis fungoides/Sezary syndrome
cutaneous B-cell non-Hodgkin lymphoma
stage III cutaneous T-cell non-Hodgkin lymphoma
stage IV cutaneous T-cell non-Hodgkin lymphoma
stage III adult T-cell leukemia/lymphoma
stage IV adult T-cell leukemia/lymphoma
anaplastic large cell lymphoma
angioimmunoblastic T-cell lymphoma
adult nasal type extranodal NK/T-cell lymphoma
Waldenstrom macroglobulinemia
adult grade III lymphomatoid granulomatosis
primary central nervous system non-Hodgkin lymphoma
intraocular lymphoma
Not provided
Intervention Model Description
Not provided
Primary Purpose
Not provided
Observational Model
Other
Time Perspective
Prospective
Masking Info
No data available
No data is available for this block.
D008228
Lymphoma, Non-Hodgkin
D016400
Lymphoma, Large-Cell, Immunoblastic
D054198
Precursor Cell Lymphoblastic Leukemia-Lymphoma
D008224
Lymphoma, Follicular
D020522
Lymphoma, Mantle-Cell
D018442
Lymphoma, B-Cell, Marginal Zone
D015451
Leukemia, Lymphocytic, Chronic, B-Cell
D009182
Mycosis Fungoides
D012751
Sezary Syndrome
D016410
Lymphoma, T-Cell, Cutaneous
D054218
Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
D017728
Lymphoma, Large-Cell, Anaplastic
D007119
Immunoblastic Lymphadenopathy
D054391
Lymphoma, Extranodal NK-T-Cell
D008258
Waldenstrom Macroglobulinemia
D064090
Intraocular Lymphoma
D005261
Female Urogenital Diseases and Pregnancy Complications