Hepatic CancerNCT00923052
The Natural History of Solid Organ Cancer Stem Cells (SOCSC)
An observational study of Hepatic Cancer and Pancreatic Ductal Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: Researchers are trying to learn what causes certain types of cancer to spread to other organs in the body (metastasis). Cancer tumors may produce a very small number of specific cells (cancer stem cells) that cause the tumors to grow in other organs throughout the body. Read more about this study
- Who is it for?
- Ages 16 to 100 years
- Conditions the study is for
- Hepatic Cancer, Pancreatic Ductal Cancer, Colorectal Cancer
- How many people
- 190 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2009to 7 May 2015
- 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 16 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
- INCLUSION CRITERIA: (Beginning with amendment J, all patients must meet the first eligibility criteria a. Patients scheduled to underg surgery must meet criteria b-e.)
- Patients with radiographic evidence of, biochemical evidence of, and/or histologically/cytologically proven solid organ cancer, including hepatobiliary cancer, pancreatic cancer, colorectal cancer, gastric cancer, breast cancer, adrenal cancer, mesothelioma, anal cancer, female reproductive tract cancer (ovarian, uterine and cervical), melanoma, and sarcoma.
- Patients with rare solid organ cancers including but not limited to small intestine, vagina, vulva, carcinoid, skin, pediatric cancers, Kaposi s sarcoma, and cancers of unknown origin.
- Patients with premalignant neoplasms who are scheduled to undergo surgery or biopsy as part of their diagnostic evaluation.
- Patients with a family history of familial or hereditary solid organ cancers or a clinical suspicion for a familial cancer (these patients may show no evidence of disease at the time of enrollment).
- Patients must have an ECOG performance score of 0-2.
- Patients must be 16 years of age or older.
- Patients must have laboratory and physical examination parameters within acceptable limits by standard of practice guidelines prior to biopsy or surgery. Note: Not applicable for healthy relatives having blood analyzed for DNA only.
- Patients must be seronegative for HIV antibody, Hepatitis B surface antigen and Hepatitis C antibody, with the exception of patients with hepatocellular cancers, who must be seronegative for HIV antibody only. Note: Not applicable for healthy relatives having blood analyzed for DNA only.
- Patients undergoing treatment for their neoplasm under other current NIH protocols may be eligible.
Note: Patients will not undergo surgery or biopsy for the sole purpose of tissue procurement.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Background:
- Researchers are trying to learn what causes certain types of cancer to spread to other organs in the body (metastasis). Cancer tumors may produce a very small number of specific cells (cancer stem cells) that cause the tumors to grow in other organs throughout the body.
- By examining cancer tumor tissue, normal tissue, blood, bone marrow, and other body fluids, researchers may determine whether these samples contain cancer stem cells. Cancer stem cells may provide information on whether the cancer will come back or spread before other routine x-ray studies or lab tests indicate its presence.
Read more
Objectives:
- To acquire a collection of solid organ cancer stem cells for future study.
- To analyze solid organ cancer stem cells from various types of cancer on a genetic level.
- To determine if solid organ cancer stem cells are present in the blood or bone marrow.
Eligibility:
- Patients 16 years of age and older who have solid organ cancer (cancer in the liver, colon, rectum, anus, pancreas, stomach, breast, skin, muscles, fat, connective tissue, uterus, ovary, cervix, vagina, vulva, or inner lining of the abdomen) or a precancerous growth, and who are scheduled to have a biopsy or surgery to remove the cancer as part of their treatment.
Design:
- This is a prospective trial designed to procure solid organ cancer stem cells before either surgery or biopsy.
- All patients registered to this trial will undergo surgery to extirpate their cancer in the NCI
- Prior to surgery or biopsy, 8 tablespoons of blood will be drawn.
- During the surgery or biopsy, a sample of normal tissue will be removed along with the cancerous or precancerous tissue. If separate consent is given, samples of bone marrow will also be taken.
- After discharge, patients will return to the clinic for routine visits every month for the first 3 months following surgery, and then about every 3 months for 2 years, and then every 6 months for 3 years. During the visits, patients will have routine blood and imaging studies done, and researchers will take additional blood samples (about 8 tablespoons at each visit) and optional bone marrow samples (4 teaspoons every 6 months) to be used for research.
Read the detailed description
Background:
- Traditional models of cancer metastasis posit that cancer metastases might originate stochastically in any cancer cell while, the Cancer-Stem-Cell hypothesis suggests that the metastasizing cells are Solid Organ Cancer Stem Cells (SOCSC).
- SOCSC are relatively resistant to current cancer therapies. Thus, effective treatment for metastatic cancers might require the targeting of SOCSC.
- Knowledge on SOCSC is chiefly derived from cell lines. However, data suggest vast differences between cell lines and SOCSC obtained from fresh tumors.
- This protocol is designed to facilitate fresh tissue procurement to study SOCSC.
Primary Objective:
-To study the natural history of SOCSC from various primary and metastatic solid organ cancers using established phenotypic and functional markers.
Secondary Objectives:
- To analyze SOCSC for potential targets that can be used to design novel cancer therapies that target cancer stem cells.
- To determine whether SOCSC are present in the blood and/or bone marrow, and study their quantitative and/or qualitative changes from time of surgical resection to time of recurrence and/or metastasis.
- To evaluate the potential of SOCSC and their quantitative and/or qualitative changes over time after surgery, to be used in future studies as biomarkers for the early detection of cancer recurrence and/or metastases.
- To collect detailed history, demographic, and treatment data as well as perioperative findings to evaluate potential correlation with the presence or absence of SOCSC.
- To develop an animal model to investigate potential interaction between bone marrow derived stem cells and solid organ cancers.
- To observe the course of normal stem cells over time in patients who had benign tumors that do not show evidence of cancer over time.
- To compare the course of normal stem cells with that of stem cells from patients with solid organ cancers.
- To specifically investigate families with clusters of cancer to determine if there is a relationship between SOCSC and potential familial genetic mutations specific to a particular cancer and if present, to compare these genetic abnormalities with individuals from the same family without cancer.
Eligibility:
- Patients 16 years of age or older with primary or metastatic solid organ cancers requiring resection or other cancer directed therapy that is deemed in the best interest of their cancer care.
- Patients with premalignant neoplasms who are scheduled to undergo surgery or biopsy as part of their diagnostic evaluation.
- Patients must have an ECOG performance score of 0-2.
- Patients must have laboratory and physical examination parameters within acceptable limits by standard of practice guidelines prior to biopsy or surgery.
Design:
- This is a prospective trial designed to procure SOCSC from various benign and solid organ cancers tumors (primary or metastatic) and follow their natural history from time of surgery and or other cancer directed therapy to time of recurrence.
- SOCSC will be isolated using phenotypic and functional markers. Investigations will be performed on the following tissues: Blood prior and after surgery, tumor and adjacent normal tissue when available, bone marrow (strictly optional under separate consent), and peritoneal washings when applicable.
- After surgery blood will be drawn at 1 and 3 months and every 3-6 months thereafter during the follow-up period (5 years). Bone marrow may be analyzed every six months during the follow-up period (strictly optional).
- Patients will be followed with standard of care or other cancer directed therapy deemed in the best interest of the patient.
- It is anticipated that between 274 and 676 patients will be enrolled over a period of 5 years (2-5 patients per month).
- Conditions
- Hepatic Cancer, Pancreatic Ductal Cancer, Colorectal Cancer, Breast Cancer, Gastric Cancer
- Keywords
- Cancer Stem Cells, Biomarkers, Surgery, Solid Organ Cancers, Natural History, Cancer, Solid Organ Cancer, Liver Cancer, Colorectal Cancer, Breast Cancer, Gastric Cancer, Pancreatic Ductal Cancer
- Medical subject headings
- Liver Neoplasms, Colorectal Neoplasms, Breast Neoplasms, Stomach Neoplasms, Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
To study and characterize both quantitatively and qualitatively SOCSC from various primary and metastatic solid organ cancers from time of surgery or other cancer directed therapy to time of recurrence or progression using an exhaustive list of ...
Secondary outcomes (1)
To determine whether SOCSC are present in the blood and/or bone marrow, and study their quantitative and/or qualitative changes over the course of the disease, from time of initial presentation to time of recurrence and/or metastasis.To sp...
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2009 (estimated)
- Study start9 Feb 2009
- Study completion7 May 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hepatic CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- 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
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Udo Rudloff, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00923052
- Sponsor's protocol ID
- 090079
- Other IDs
- 09-C-0079
- Status last verified
- 7 May 2015
- First submitted
- 17 Jun 2009
- Last updated
- 16 Dec 2019
- Results posted
- No
Publications
Fidler IJ. Critical factors in the biology of human cancer metastasis: twenty-eighth G.H.A. Clowes memorial award lecture. Cancer Res. 1990 Oct 1;50(19):6130-8.
PubMed 1698118Fidler IJ. Critical factors in the biology of human cancer metastasis. Am Surg. 1995 Dec;61(12):1065-6. No abstract available.
PubMed 7486447Fidler IJ. Critical determinants of melanoma metastasis. J Investig Dermatol Symp Proc. 1996 Apr;1(2):203-8.
PubMed 9627717
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Natural History of Solid Organ Cancer Stem Cells (SOCSC)
- ClinicalTrials.gov ID
- NCT00923052
- Acronym / sponsor ID
- 090079
- Conditions
- Hepatic Cancer, Pancreatic Ductal Cancer, Colorectal Cancer, Breast Cancer, Gastric Cancer
- Keywords
- Cancer Stem Cells, Biomarkers, Surgery, Solid Organ Cancers, Natural History, Cancer, Solid Organ Cancer, Liver Cancer
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 190 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 9 Feb 2009
- Study completion
- 7 May 2015
- First posted
- 18 Jun 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.
Background:
- Researchers are trying to learn what causes certain types of cancer to spread to other organs in the body (metastasis). Cancer tumors may produce a very small number of specific cells (cancer stem cells) that cause the tumors to grow in other organs throughout the body.
- By examining cancer tumor tissue, normal tissue, blood, bone marrow, and other body fluids, researchers may determine whether these samples contain cancer stem cells. Cancer stem cells may provide information on whether the cancer will come back or spread before other routine x-ray studies or lab tests indicate its presence.
Objectives:
- To acquire a collection of solid organ cancer stem cells for future study.
- To analyze solid organ cancer stem cells from various types of cancer on a genetic level.
- To determine if solid organ cancer stem cells are present in the blood or bone marrow.
Eligibility:
- Patients 16 years of age and older who have solid organ cancer (cancer in the liver, colon, rectum, anus, pancreas, stomach, breast, skin, muscles, fat, connective tissue, uterus, ovary, cervix, vagina, vulva, or inner lining of the abdomen) or a precancerous growth, and who are scheduled to have a biopsy or surgery to remove the cancer as part of their treatment.
Design:
- This is a prospective trial designed to procure solid organ cancer stem cells before either surgery or biopsy.
- All patients registered to this trial will undergo surgery to extirpate their cancer in the NCI
- Prior to surgery or biopsy, 8 tablespoons of blood will be drawn.
- During the surgery or biopsy, a sample of normal tissue will be removed along with the cancerous or precancerous tissue. If separate consent is given, samples of bone marrow will also be taken.
- After discharge, patients will return to the clinic for routine visits every month for the first 3 months following surgery, and then about every 3 months for 2 years, and then every 6 months for 3 years. During the visits, patients will have routine blood and imaging studies done, and researchers will take additional blood samples (about 8 tablespoons at each visit) and optional bone marrow samples (4 teaspoons every 6 months) to be used for research.
Detailed description
Background:
- Traditional models of cancer metastasis posit that cancer metastases might originate stochastically in any cancer cell while, the Cancer-Stem-Cell hypothesis suggests that the metastasizing cells are Solid Organ Cancer Stem Cells (SOCSC).
- SOCSC are relatively resistant to current cancer therapies. Thus, effective treatment for metastatic cancers might require the targeting of SOCSC.
- Knowledge on SOCSC is chiefly derived from cell lines. However, data suggest vast differences between cell lines and SOCSC obtained from fresh tumors.
- This protocol is designed to facilitate fresh tissue procurement to study SOCSC.
Primary Objective:
-To study the natural history of SOCSC from various primary and metastatic solid organ cancers using established phenotypic and functional markers.
Secondary Objectives:
- To analyze SOCSC for potential targets that can be used to design novel cancer therapies that target cancer stem cells.
- To determine whether SOCSC are present in the blood and/or bone marrow, and study their quantitative and/or qualitative changes from time of surgical resection to time of recurrence and/or metastasis.
- To evaluate the potential of SOCSC and their quantitative and/or qualitative changes over time after surgery, to be used in future studies as biomarkers for the early detection of cancer recurrence and/or metastases.
- To collect detailed history, demographic, and treatment data as well as perioperative findings to evaluate potential correlation with the presence or absence of SOCSC.
- To develop an animal model to investigate potential interaction between bone marrow derived stem cells and solid organ cancers.
- To observe the course of normal stem cells over time in patients who had benign tumors that do not show evidence of cancer over time.
- To compare the course of normal stem cells with that of stem cells from patients with solid organ cancers.
- To specifically investigate families with clusters of cancer to determine if there is a relationship between SOCSC and potential familial genetic mutations specific to a particular cancer and if present, to compare these genetic abnormalities with individuals from the same family without cancer.
Eligibility:
- Patients 16 years of age or older with primary or metastatic solid organ cancers requiring resection or other cancer directed therapy that is deemed in the best interest of their cancer care.
- Patients with premalignant neoplasms who are scheduled to undergo surgery or biopsy as part of their diagnostic evaluation.
- Patients must have an ECOG performance score of 0-2.
- Patients must have laboratory and physical examination parameters within acceptable limits by standard of practice guidelines prior to biopsy or surgery.
Design:
- This is a prospective trial designed to procure SOCSC from various benign and solid organ cancers tumors (primary or metastatic) and follow their natural history from time of surgery and or other cancer directed therapy to time of recurrence.
- SOCSC will be isolated using phenotypic and functional markers. Investigations will be performed on the following tissues: Blood prior and after surgery, tumor and adjacent normal tissue when available, bone marrow (strictly optional under separate consent), and peritoneal washings when applicable.
- After surgery blood will be drawn at 1 and 3 months and every 3-6 months thereafter during the follow-up period (5 years). Bone marrow may be analyzed every six months during the follow-up period (strictly optional).
- Patients will be followed with standard of care or other cancer directed therapy deemed in the best interest of the patient.
- It is anticipated that between 274 and 676 patients will be enrolled over a period of 5 years (2-5 patients per month).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 study and characterize both quantitatively and qualitatively SOCSC from various primary and metastatic solid organ cancers from time of surgery or other cancer directed therapy to time of recurrence or progression using an exhaustive list of ...
1 secondary outcome
To determine whether SOCSC are present in the blood and/or bone marrow, and study their quantitative and/or qualitative changes over the course of the disease, from time of initial presentation to time of recurrence and/or metastasis.To sp...
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2019.
- Background: PubMed 1698118Fidler IJ. Critical factors in the biology of human cancer metastasis: twenty-eighth G.H.A. Clowes memorial award lecture. Cancer Res. 1990 Oct 1;50(19):6130-8.
- Background: PubMed 7486447Fidler IJ. Critical factors in the biology of human cancer metastasis. Am Surg. 1995 Dec;61(12):1065-6. No abstract available.
- Background: PubMed 9627717Fidler IJ. Critical determinants of melanoma metastasis. J Investig Dermatol Symp Proc. 1996 Apr;1(2):203-8.
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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.
Udo Rudloff, M.D. principal investigator
National Cancer Institute (NCI)
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 Hepatic Cancer and Pancreatic Ductal Cancer, run by National Cancer Institute (NCI) 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?
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: stopped early, as of the sponsor's last update on 16 Dec 2019. 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 was stopped early. Results are not available in the source record.
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 study and characterize both quantitatively and qualitatively SOCSC from various primary and metastatic solid organ cancers from time of surgery or other cancer directed therapy to time of recurrence or progression using an exhaustive list of .... 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 NCT00923052, which also lists 3 linked publications.
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 16 Dec 2019.