CancerMiCKNCT00901264
Microculture Kinetic (MiCK) Apoptosis Test Results With Drug Treatment Results in Cancer Patients
An observational study of Cancer, run by Pierian Biosciences at 11 sites in 2 countries.
Trial summary
The purpose of this study is to correlate the results of the MICK assay with short- and long-term results of treatments in cancer patients and evaluate the role of the MiCK assay in guiding chemotherapy of cancer patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cancer
- How many people
- 300 participants
- Where
- 11 sitesin 2 countries
- Study dates
- Dec 2008to Nov 2012
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Cancer Patients for whom chemotherapy is planned.
Who may be able to join
- 3.1.1 Patients with pathological diagnoses of cancer or leukemia
- 3.1.2 Patients must have tumor which is accessible for biopsy and agree to undergo tumor biopsy, or drainage of malignant effusion, and the specimen must be submitted for MiCK assay.
- 3.1.3 Patients for whom chemotherapy is planned.
Who cannot join
- 3.2.1 Patients with symptomatic/uncontrolled parenchymal brain or meningeal metastasis and tumors not accessible for biopsy.
- 3.2.2 Patients who are pregnant. Pregnancy. During the course of the study, all patients of childbearing potential should be instructed to contact the treating physician if they suspect they might have conceived a child; for females, a missing or late menstrual period should be reported to the treating physician. If pregnancy is confirmed by a pregnancy test, the patient must not receive chemotherapy in this study and must not be enrolled into the study or, if already enrolled, must be withdrawn from the study. If a male patient is suspected of having fathered a child while on the study, the pregnant female partner must be notified and counseled regarding the risk to the fetus. Pregnancy during the course of this study will be reported to the Principal Investigator as a serious adverse event. Women of child bearing potential are defined to include any female who has experienced menarche and has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not post-menopausal (defined as amenorrhea for more than 12 consecutive months); these includes also females using oral, implanted, or injectable contraceptive hormones, mechanical devices, or barrier methods to prevent pregnancy.
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
United States10 sites
DiaTech Oncology
Brentwood, Tennessee, 37027
Cumberland Medical Center
Crossville, Tennessee, 38555
Wilshire Oncology Medical Group, Inc
La Verne, California, 91750
Middle Tennessee Medical Center
Murfreesboro, Tennessee, 37219
Baptist Hospital
Nashville, Tennessee, 37203
Nashville Oncology Associates
Nashville, Tennessee, 37203
St. Thomas Research Institute, LLC
Nashville, Tennessee, 37203
Tennessee Breast Specialists
Nashville, Tennessee, 37203
Tennessee Toracic Surgical Specialists
Nashville, Tennessee, 37205
Tampa General Hospital
Tampa, Florida, 33606
About this study
Official title: Correlation of the Microculture Kinetic (MiCK) Apoptosis Test Results With Drug Treatment Results in Cancer Patients
The purpose of this study is to correlate the results of the MICK assay with short- and long-term results of treatments in cancer patients and evaluate the role of the MiCK assay in guiding chemotherapy of cancer patients.
Read the detailed description
Identification of those patients with cancer who will or will not respond to a specific chemotherapy is important for making decisions regarding chemotherapy regimens as well as alternative management approaches. A laboratory test that could help to determine the sensitivity of an individual patient's tumor cells to specific chemotherapeutic agents would be valuable in choosing the optimal chemotherapy regimen for that patient with an expectation of increasing the response rate to the therapy. Several types of in vitro assays that measure tumor cell survival following exposure to cytotoxic agents have been evaluated for their ability to predict chemotherapy outcomes. As a group, these assays are referred to as drug resistance assays. In a resistance assay, the surviving tumor cells can be detected directly by their exclusion or metabolism of specific dyes. Alternatively, since some of tumor cells are proliferating, their survival can be detected by measurement of DNA synthesis by radiolabeled precursor incorporation or demonstration of clonogenic potential by growth into colonies in semi-solid culture medium. In several clinical studies, these assays were useful in detecting drug resistance and in predicting a poor prognosis for cancer patients. However, these resistance assays cannot detect sensitivity of an individual patient's tumor cells to a specific drug. Therefore, new methods determining drug-sensitivity of the tumor cells of an individual patient and, thus, capable of both predicting a positive treatment outcome and guiding chemotherapy, would be of significant value.
Recently, an automated microculture kinetic (MiCK) assay for measuring drug induced apoptosis in tumor cells has been developed1-4. Apoptosis is a distinct mode of cell death which occurs under physiological conditions and yet can be induced in malignant cells by chemical and physical factors including antitumor drugs5-7. During the last decade, it has been recognized that chemotherapeutic agents exert their antitumor activity by triggering apoptosis in susceptible tumor cells8-17. This implies that the MiCK assay for apoptosis provides a mechanism-based approach to studying effects of cytotoxic agents on tumor cells. Unlike "resistance" assays that measure a fraction of cells surviving drug exposure, the MiCK assay measures a fraction of tumor cells killed by a chemotherapeutic agent via mechanism of apoptosis. Therefore the MiCK assay determines drug sensitivity, rather than resistance. Recently the MiCK assay has been shown to predict complete remission rate and survival in acute myeloid leukemia patients better than clinical criteria did18-20. In a limited study, the MiCK assay has been used to direct chemotherapy of the leukemia patients 21.
The MiCK assay has also been used to study drug-induced apoptosis in solid tumors, including neuroblastoma and colon adenocarcinoma cell lines22-23. More recent data accumulated by DiaTech has demonstrated that the MiCK assay can detect drug induced apoptosis in primary cultures of tumor cells isolated from patients with ovarian carcinoma, gastric carcinoma, metastatic breast cancer and high grade soft tissue sarcoma. The purpose of this study is to correlate the results of the MICK assay with short- and long-term results of treatments in cancer patients and evaluate the role of the MiCK assay in guiding chemotherapy of cancer patients.
- Conditions
- Cancer
- Keywords
- Chemosensitivity, chemotherapy, all cancers, personalized chemotherapy, personalized cancer treatment, Cancer Patients for whom chemotherapy is planned.
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients with pathological diagnoses of cancer or leukemia | |
| 2 | 3.1.3 Patients for whom chemotherapy is planned. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the ability of the MiCK assay to guide chemotherapy of cancer patients, with emphasis on patients failing primary treatment, patients with unknown primary tumors, and patients with tumors difficult to treat such as carcinoma of lung.
Measured: one year
Secondary outcomes (1)
Correlate the MiCK assay results with objective response rates, symptom response rates, time to progression and survival of cancer patients treated with chemotherapy.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2009 (estimated)
- Study startDec 2008
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierian Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cary Presant, MD, Study director, Pierian BiosciencesDirk Davidson, MD, Principal investigator, Cumberland Medical CenterKarl Rogers, MD, Principal investigator, Nashville Oncology AssociatesSwapnil P. Rajurkar, MD, Principal investigator, Wilshire Oncology Medical Group, Inc.Laura Lawson, MD, Principal investigator, Tennessee Breast SpecialistsL. James Wudel Jr., MD, Principal investigator, Tennessee Thoracic Surgical SpecialistsRaymond F Bluth, MD, Principal investigator, Baptist Hospital NashvillePeter F Jelsma, MD, Principal investigator, St. Thomas Research Institute, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00901264
- Sponsor's protocol ID
- Master Study DiaTech Oncology
- Acronym
- MiCK
- Status last verified
- Nov 2012
- First submitted
- 12 May 2009
- Last updated
- 14 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Bosserman L, Rogers K, Willis C, Davidson D, Whitworth P, Karimi M, Upadhyaya G, Rutledge J, Hallquist A, Perree M, Presant CA. Application of a drug-induced apoptosis assay to identify treatment strategies in recurrent or metastatic breast cancer. PLoS One. 2015 May 29;10(5):e0122609. doi: 10.1371/journal.pone.0122609. eCollection 2015.
PubMed 26024531
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of the Microculture Kinetic (MiCK) Apoptosis Test Results With Drug Treatment Results in Cancer Patients
- ClinicalTrials.gov ID
- NCT00901264
- Acronym / sponsor ID
- MiCK / Master Study DiaTech Oncology
- Conditions
- Cancer
- Keywords
- Chemosensitivity, chemotherapy, all cancers, personalized chemotherapy, personalized cancer treatment, Cancer Patients for whom chemotherapy is planned.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Pierian BiosciencesIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 13 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.
The purpose of this study is to correlate the results of the MICK assay with short- and long-term results of treatments in cancer patients and evaluate the role of the MiCK assay in guiding chemotherapy of cancer patients.
Detailed description
Identification of those patients with cancer who will or will not respond to a specific chemotherapy is important for making decisions regarding chemotherapy regimens as well as alternative management approaches. A laboratory test that could help to determine the sensitivity of an individual patient's tumor cells to specific chemotherapeutic agents would be valuable in choosing the optimal chemotherapy regimen for that patient with an expectation of increasing the response rate to the therapy. Several types of in vitro assays that measure tumor cell survival following exposure to cytotoxic agents have been evaluated for their ability to predict chemotherapy outcomes. As a group, these assays are referred to as drug resistance assays. In a resistance assay, the surviving tumor cells can be detected directly by their exclusion or metabolism of specific dyes. Alternatively, since some of tumor cells are proliferating, their survival can be detected by measurement of DNA synthesis by radiolabeled precursor incorporation or demonstration of clonogenic potential by growth into colonies in semi-solid culture medium. In several clinical studies, these assays were useful in detecting drug resistance and in predicting a poor prognosis for cancer patients. However, these resistance assays cannot detect sensitivity of an individual patient's tumor cells to a specific drug. Therefore, new methods determining drug-sensitivity of the tumor cells of an individual patient and, thus, capable of both predicting a positive treatment outcome and guiding chemotherapy, would be of significant value.
Recently, an automated microculture kinetic (MiCK) assay for measuring drug induced apoptosis in tumor cells has been developed1-4. Apoptosis is a distinct mode of cell death which occurs under physiological conditions and yet can be induced in malignant cells by chemical and physical factors including antitumor drugs5-7. During the last decade, it has been recognized that chemotherapeutic agents exert their antitumor activity by triggering apoptosis in susceptible tumor cells8-17. This implies that the MiCK assay for apoptosis provides a mechanism-based approach to studying effects of cytotoxic agents on tumor cells. Unlike "resistance" assays that measure a fraction of cells surviving drug exposure, the MiCK assay measures a fraction of tumor cells killed by a chemotherapeutic agent via mechanism of apoptosis. Therefore the MiCK assay determines drug sensitivity, rather than resistance. Recently the MiCK assay has been shown to predict complete remission rate and survival in acute myeloid leukemia patients better than clinical criteria did18-20. In a limited study, the MiCK assay has been used to direct chemotherapy of the leukemia patients 21.
The MiCK assay has also been used to study drug-induced apoptosis in solid tumors, including neuroblastoma and colon adenocarcinoma cell lines22-23. More recent data accumulated by DiaTech has demonstrated that the MiCK assay can detect drug induced apoptosis in primary cultures of tumor cells isolated from patients with ovarian carcinoma, gastric carcinoma, metastatic breast cancer and high grade soft tissue sarcoma. The purpose of this study is to correlate the results of the MICK assay with short- and long-term results of treatments in cancer patients and evaluate the role of the MiCK assay in guiding chemotherapy of cancer patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients with pathological diagnoses of cancer or leukemia |
| 2 | – | –3.1.3 Patients for whom chemotherapy is planned. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Cancer Patients for whom chemotherapy is planned.
Key inclusion criteria (3 listed)
- 3.1.1 Patients with pathological diagnoses of cancer or leukemia
- 3.1.2 Patients must have tumor which is accessible for biopsy and agree to undergo tumor biopsy, or drainage of malignant effusion, and the specimen must be submitted for MiCK assay.
- 3.1.3 Patients for whom chemotherapy is planned.
Key exclusion criteria (2 listed)
- 3.2.1 Patients with symptomatic/uncontrolled parenchymal brain or meningeal metastasis and tumors not accessible for biopsy.
- 3.2.2 Patients who are pregnant. Pregnancy. During the course of the study, all patients of childbearing potential should be instructed to contact the treating physician if they suspect they might have conceived a child; for females, a missing or late menstrual period should be reported to the treating physician. If pregnancy is confirmed by a pregnancy test, the patient must not receive chemotherapy in this study and must not be enrolled into the study or, if already enrolled, must be withdrawn from the study. If a male patient is suspected of having fathered a child while on the study, the pregnant female partner must be notified and counseled regarding the risk to the fetus. Pregnancy during the course of this study will be reported to the Principal Investigator as a serious adverse event. Women of child bearing potential are defined to include any female who has experienced menarche and has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not post-menopausal (defined as amenorrhea for more than 12 consecutive months); these includes also females using oral, implanted, or injectable contraceptive hormones, mechanical devices, or barrier methods to prevent pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To evaluate the ability of the MiCK assay to guide chemotherapy of cancer patients, with emphasis on patients failing primary treatment, patients with unknown primary tumors, and patients with tumors difficult to treat such as carcinoma of lung.
Time frame: one year
1 secondary outcome
Correlate the MiCK assay results with objective response rates, symptom response rates, time to progression and survival of cancer patients treated with chemotherapy.
Time frame: one year
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 14 Nov 2012.
- Derived from this study: PubMed 26024531Bosserman L, Rogers K, Willis C, Davidson D, Whitworth P, Karimi M, Upadhyaya G, Rutledge J, Hallquist A, Perree M, Presant CA. Application of a drug-induced apoptosis assay to identify treatment strategies in recurrent or metastatic breast cancer. PLoS One. 2015 May 29;10(5):e0122609. doi: 10.1371/journal.pone.0122609. eCollection 2015.
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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.
Cary Presant, MD study director
Pierian Biosciences
Dirk Davidson, MD principal investigator
Cumberland Medical Center
Karl Rogers, MD principal investigator
Nashville Oncology Associates
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Pierian Biosciences at 11 sites in 2 countries.
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 3 inclusion and 2 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 14 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Canada. 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?
To evaluate the ability of the MiCK assay to guide chemotherapy of cancer patients, with emphasis on patients failing primary treatment, patients with unknown primary tumors, and patients with tumors difficult to treat such as carcinoma of lung. (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00901264, which also lists 1 linked publication.
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 14 Nov 2012.