Oral CancerNCT00173849
The Role of SDF-1/CXCR4 in Metastasis of Oral Squamous Cell Carcinoma
An observational study of Oral Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Investigate the role of SDF-1/CXCR4 in the metastasis of oral squamous cell carcinoma Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Oral Cancer
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2006to Jul 2006
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Oral squamous cell carcinoma
Who cannot join
- other pathological type
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Taiwan University Hospital
Taipei, 100
Ching-Ting Tan, MD, PhD, 886-2-23123456 ext. 5222, christin@ha.mc.ntu.edu.tw
About this study
Investigate the role of SDF-1/CXCR4 in the metastasis of oral squamous cell carcinoma
Read the detailed description
Oral cancer is the most common head and neck malignancy, constituting near 9% of all cancers (1). Squamous cell carcinoma (SCC) is the most common histopathologic type of the oral malignancies, accounting for more than 90% of cancers occurring in this region (2). The presence or absence of regional lymph node metastases is the single most important factor affecting prognosis in patients with oral cancer. Cure rates for oral cancer are decreased by approximately 50 percent in patients having cervical lymph node metastasis (3).
Tumor metastasis is the hallmark of malignancy, and is probably a result of the interaction between tumor cells and a supportive microenvironment. Malignant cells that have the capability to metastasize to a particular organ may have various properties supporting their tissue invasion or growth such as enhanced adherence to the microvascular cells of the organ, higher responsiveness to chemotactic signals released from the target organs and increased response to local soluble or tissue associated growth signals in the target organ (4,5). Though there are several molecules expressed or produced in cancer cells are considered the metastatic factors, it remains unknown which factors produced by the lymph node or tissue affect the metastasis of cancer cells.
Chemokines are a large family of pro-inflammatory polypeptide cytokines, consisting of small (7-15 kDa), structurally related heparin-binding proteins. They are grouped into CXC chemokines and CC chemokines, on the basis of the characteristic presence of four conserved cysteine residues (6-8). Chemokines are produced locally in the tissues and act on target cells through G-protein-coupled receptors, which are characterized structurally by seven transmembrane spanning domains. Chemokines are involved in the attraction and activation of mononuclear and polymorphonuclear leukocytes to sites of inflammatory responses, bacterial or viral infections, allergy, cardiovascular diseases and wound healing (4, 8-13). Chemokines are known to also function as regulatory molecules in the leukocyte maturation, trafficking, and homing of T and B lymphocytes, in the development of lymphoid tissues, and in dendritic cell maturation (14,15). Other functions of chemokines have been described more recently, particularly for the CXC chemokines. The role of chemokines in malignant tumors is not clear yet. Some chemokines may enhance innate or specific host immunity against tumor dissemination. On the other hand, some may advocate tumor growth and metastasis by promoting tumor cell proliferation, migration or angiogenesis in tumor tissue (4). Reports have suggested that several types of cancer, such as breast (16), ovary (17), prostate (18), kidney (19), brain (20), lung (21), and thyroid (22), expressed the chemokine receptor and used the chemokines to metastasize to the target organ as in the homing of hematopoietic cells.
SDF-1 belongs to the CXC chemokine family and is a ligand for CXCR4 (23, 24). SDF-1 was initially cloned by Tashiro et al. (25) and later identified as a growth factor for B cell progenitors, a chemotactic factor for T cells and monocytes, and in B-cell lymphopoiesis and bone marrow myelopoiesis (23, 26-27). Most of the chemokine receptors interact with pleural ligands, and vice versa, but the SDF-1/CXCR4 receptor ligand system has been shown to involve a one-on-one interaction (28, 29). Recently, several studies have been conducted to detect the mRNA expression of CXCR4 and SDF-1 in solid tumors. The results are not uniform, and the relevance to cancer progression is not determined (30, 31). Sehgal et al. (30, 32) concluded that CXCR4 plays an important role of proliferation and tumorigenic properties of human glioblastoma tumors. Muller et al. (33) have reported that SDF-1 signaling through CXCR4 interaction appears to determine the directional migration of breast cancer cells through the basement membrane. Furthermore in vivo, the interaction between SDF-1 and CXCR4 significantly represses the metastatic potential of breast cancer cells to lymph node and lung. Barnard and his colleagues (34, 35) showed the contrary results that CXCR4 mRNA expression was reduced in hepatocellular carcinoma tissue when compared with noncancerous tissue, but was not changed in colon, esophageal, and gastric cancer. They also found reduced mRNA expression of SDF-1 in these malignant tissues (31). Thus, there is a diversity of views on the role of the SDF-1/CXCR4 receptor ligand system in malignant tissues. And such studies are limited in oral cancer.
Since metastasis of oral cancer occur frequently through the lymphatic system, and metastasis is a key prognostic factor for the disease. Evaluation of the relationship between SDF-1/CXCR4 system and metastasis in oral cancer could help us understand whether this system is important in the metastasis of this disease.
We hypothesized that SDF-1/CXCR4 (ligand/receptor) system plays an important role in oral cancer metastasis. To test this hypothesis, we will investigate (1) the distribution of CXCR4 protein expression in cancer and lymph node tissues by means of immunohistochemical analysis of tissue samples obtained from surgical operation, (2) the relationship between CXCR4 expression and clinicopathological findings with special reference to cancer metastasis, (3) the expression of SDF-1 and CXCR4 in the cancer cell lines cells and tissues, (4) the chemotactic activity and the growth-promoting effect of SDF-1 on cancer cell lines cells, (5) the role of Src, MAPK, and Akt signal transduction pathway in this response, (6) the effect of the blocking agent on this response.
Undoubtedly, the findings of this study will help us understand whether SDF-1/CXCR4 system could be a focal point of anti-cancer research. If oral SCC that express high levels of CXCR4 show a consistently higher incidence of lymphatic and distant metastasis, then blocking SDF-1/CXCR4 signaling may be a novel approach to inhibit metastasis in these patients. The development of SDF-1/CXCR4 system antagonists will provide opportunity to improve the survival rate.
- Conditions
- Oral Cancer
- Keywords
- oral cancer, CXCR4, stromal-cell-derived factor-1(SDF-1), metastasis
- Medical subject headings
- Mouth Neoplasms, Neoplasm Metastasis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJan 2006
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Natural history
- Time perspective
- Other
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Ching-Ting Tan, MD, PhD, Principal investigator, National Taiwan University Hospita;
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00173849
- Sponsor's protocol ID
- 9461700656
- Status last verified
- Jun 2005
- First submitted
- 13 Sep 2005
- Last updated
- 15 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of SDF-1/CXCR4 in Metastasis of Oral Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT00173849
- Acronym / sponsor ID
- 9461700656
- Conditions
- Oral Cancer
- Keywords
- oral cancer, CXCR4, stromal-cell-derived factor-1(SDF-1), metastasis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jan 2006
- Study completion
- Jul 2006
- First posted
- 15 Sep 2005 (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.
Investigate the role of SDF-1/CXCR4 in the metastasis of oral squamous cell carcinoma
Detailed description
Oral cancer is the most common head and neck malignancy, constituting near 9% of all cancers (1). Squamous cell carcinoma (SCC) is the most common histopathologic type of the oral malignancies, accounting for more than 90% of cancers occurring in this region (2). The presence or absence of regional lymph node metastases is the single most important factor affecting prognosis in patients with oral cancer. Cure rates for oral cancer are decreased by approximately 50 percent in patients having cervical lymph node metastasis (3).
Tumor metastasis is the hallmark of malignancy, and is probably a result of the interaction between tumor cells and a supportive microenvironment. Malignant cells that have the capability to metastasize to a particular organ may have various properties supporting their tissue invasion or growth such as enhanced adherence to the microvascular cells of the organ, higher responsiveness to chemotactic signals released from the target organs and increased response to local soluble or tissue associated growth signals in the target organ (4,5). Though there are several molecules expressed or produced in cancer cells are considered the metastatic factors, it remains unknown which factors produced by the lymph node or tissue affect the metastasis of cancer cells.
Chemokines are a large family of pro-inflammatory polypeptide cytokines, consisting of small (7-15 kDa), structurally related heparin-binding proteins. They are grouped into CXC chemokines and CC chemokines, on the basis of the characteristic presence of four conserved cysteine residues (6-8). Chemokines are produced locally in the tissues and act on target cells through G-protein-coupled receptors, which are characterized structurally by seven transmembrane spanning domains. Chemokines are involved in the attraction and activation of mononuclear and polymorphonuclear leukocytes to sites of inflammatory responses, bacterial or viral infections, allergy, cardiovascular diseases and wound healing (4, 8-13). Chemokines are known to also function as regulatory molecules in the leukocyte maturation, trafficking, and homing of T and B lymphocytes, in the development of lymphoid tissues, and in dendritic cell maturation (14,15). Other functions of chemokines have been described more recently, particularly for the CXC chemokines. The role of chemokines in malignant tumors is not clear yet. Some chemokines may enhance innate or specific host immunity against tumor dissemination. On the other hand, some may advocate tumor growth and metastasis by promoting tumor cell proliferation, migration or angiogenesis in tumor tissue (4). Reports have suggested that several types of cancer, such as breast (16), ovary (17), prostate (18), kidney (19), brain (20), lung (21), and thyroid (22), expressed the chemokine receptor and used the chemokines to metastasize to the target organ as in the homing of hematopoietic cells.
SDF-1 belongs to the CXC chemokine family and is a ligand for CXCR4 (23, 24). SDF-1 was initially cloned by Tashiro et al. (25) and later identified as a growth factor for B cell progenitors, a chemotactic factor for T cells and monocytes, and in B-cell lymphopoiesis and bone marrow myelopoiesis (23, 26-27). Most of the chemokine receptors interact with pleural ligands, and vice versa, but the SDF-1/CXCR4 receptor ligand system has been shown to involve a one-on-one interaction (28, 29). Recently, several studies have been conducted to detect the mRNA expression of CXCR4 and SDF-1 in solid tumors. The results are not uniform, and the relevance to cancer progression is not determined (30, 31). Sehgal et al. (30, 32) concluded that CXCR4 plays an important role of proliferation and tumorigenic properties of human glioblastoma tumors. Muller et al. (33) have reported that SDF-1 signaling through CXCR4 interaction appears to determine the directional migration of breast cancer cells through the basement membrane. Furthermore in vivo, the interaction between SDF-1 and CXCR4 significantly represses the metastatic potential of breast cancer cells to lymph node and lung. Barnard and his colleagues (34, 35) showed the contrary results that CXCR4 mRNA expression was reduced in hepatocellular carcinoma tissue when compared with noncancerous tissue, but was not changed in colon, esophageal, and gastric cancer. They also found reduced mRNA expression of SDF-1 in these malignant tissues (31). Thus, there is a diversity of views on the role of the SDF-1/CXCR4 receptor ligand system in malignant tissues. And such studies are limited in oral cancer.
Since metastasis of oral cancer occur frequently through the lymphatic system, and metastasis is a key prognostic factor for the disease. Evaluation of the relationship between SDF-1/CXCR4 system and metastasis in oral cancer could help us understand whether this system is important in the metastasis of this disease.
We hypothesized that SDF-1/CXCR4 (ligand/receptor) system plays an important role in oral cancer metastasis. To test this hypothesis, we will investigate (1) the distribution of CXCR4 protein expression in cancer and lymph node tissues by means of immunohistochemical analysis of tissue samples obtained from surgical operation, (2) the relationship between CXCR4 expression and clinicopathological findings with special reference to cancer metastasis, (3) the expression of SDF-1 and CXCR4 in the cancer cell lines cells and tissues, (4) the chemotactic activity and the growth-promoting effect of SDF-1 on cancer cell lines cells, (5) the role of Src, MAPK, and Akt signal transduction pathway in this response, (6) the effect of the blocking agent on this response.
Undoubtedly, the findings of this study will help us understand whether SDF-1/CXCR4 system could be a focal point of anti-cancer research. If oral SCC that express high levels of CXCR4 show a consistently higher incidence of lymphatic and distant metastasis, then blocking SDF-1/CXCR4 signaling may be a novel approach to inhibit metastasis in these patients. The development of SDF-1/CXCR4 system antagonists will provide opportunity to improve the survival rate.
Study design
- Observational model
- Natural history
- Time perspective
- Other
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Oral squamous cell carcinoma
Key exclusion criteria (1 listed)
- other pathological type
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2005.
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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.
Ching-Ting Tan, MD, PhD principal investigator
National Taiwan University Hospita;
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 Oral Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 15 Sep 2005. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ching-Ting Tan, MD, PhD (886-2-23123456 ext. 5222, christin@ha.mc.ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 15 Sep 2005.