CancerNCT00899496
Laboratory Assay in Determining Cancer Resistance in Patients With Metastatic Cancer and in Healthy Participants
An observational study of Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- immunological diagnostic method and physiologic testing
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to 23 Oct 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 120 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Those with metastatic cancer OR healthy individuals with no prior cancer diagnosis and who are over the age of 50.
Who may be able to join
- -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
Show all 19Show fewer
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157-1096
About this study
Official title: Pilot Study of Cancer Resistance in Humans
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.
Read the 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
- Cancer
- Being tested
- immunological diagnostic method, physiologic testing
- 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, ovarian sarcoma
- Medical subject headings
- Neoplasms, Urinary Bladder Neoplasms, Colonic Neoplasms, Carcinoma, Non-Small-Cell Lung, Pancreatic Neoplasms, Rectal Neoplasms, Carcinoma, Renal Cell, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immunological diagnostic methodOther
physiologic testingOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Cell killing ability (positive or negative)
Measured: Day 180
Percentage of cells killed
Measured: Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startSep 2005
- Primary completion23 Oct 2009
- Study completion23 Oct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Zheng Cui, PhD, Study chair, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00899496
- Sponsor's protocol ID
- CCCWFU 95A05
- Other IDs
- P30CA012197, CCCWFU-99A05, CCCWFU-BG05-342
- Status last verified
- Apr 2017
- First submitted
- 9 May 2009
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Cancer Resistance in Humans
- ClinicalTrials.gov ID
- NCT00899496
- Acronym / sponsor ID
- CCCWFU 95A05
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2005 (actual)
- Primary completion
- 23 Oct 2009 (actual)
- Study completion
- 23 Oct 2009 (actual)
- First posted
- 12 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Those with metastatic cancer OR healthy individuals with no prior cancer diagnosis and who are over the age of 50.
Key inclusion criteria (19 listed)
- Diagnosis of metastatic cancer including, but not limited to, any of the following:
- Healthy participant, meeting the following criteria:
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| immunological diagnostic method | Other | – |
| physiologic testing | Other | – |
Primary outcome
Cell killing ability (positive or negative)
Time frame: Day 180
Percentage of cells killed
Time frame: Day 180
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
Related trials for Cancer
Recruiting
MRD-Guided Postoperative Surveillance and Adaptive Treatment for Resectable Lung Cancer
Lung Neoplasms, Neoadjuvant Therapy
Active, not recruitingPhase 2
Tamoxifen Citrate or Z-Endoxifen Hydrochloride in Treating Patients With Locally Advanced or Metastatic, Estrogen Receptor-Positive, HER2-Negative Breast Cancer
Recurrent Breast Carcinoma, Stage III Breast Cancer AJCC v7
Not yet recruitingPhase 2
A Phase II Clinical Study Evaluating the Efficacy and Safety of SXRN Injection in Patients With Cancer Cachexia
Cachexia-Anorexia Syndrome, Cachexia; Cancer
RecruitingPhase 2
Adebrelimab ±Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for Unresectable Locally Advanced ESCC
Esophageal Squamous Cell Carcinoma, Immunotherapy
Not yet recruitingPhase 1/2
A Study of Sonrotoclax (BGB-11417) in Children With Relapsed or Refractory Acute Myeloid Leukemia and B-cell Acute Lymphoblastic Leukemia
Relapsed Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zheng Cui, PhD study chair
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cell killing ability (positive or negative) (time frame: Day 180). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2017.