NCT00899496

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 23, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 23, 2009

Completed
Last Updated

May 30, 2017

Status Verified

April 1, 2017

Enrollment Period

4.1 years

First QC Date

May 9, 2009

Last Update Submit

May 25, 2017

Conditions

Cancer

Keywords

stage IV bladder cancerstage IV colon cancerstage IV non-small cell lung cancerstage IV pancreatic cancerstage IV rectal cancerstage IV renal cell cancerstage IV melanomastage III multiple myelomaextensive stage small cell lung cancerstage IV adult soft tissue sarcomastage III malignant testicular germ cell tumorstage IV breast cancerstage IV ovarian epithelial cancerstage IV prostate cancerstage IV endometrial carcinomaunspecified adult solid tumor, protocol specificmetastatic osteosarcomastage IV uterine sarcomastage III ovarian epithelial cancerovarian sarcomastage IV adult Burkitt lymphomastage III adult diffuse large cell lymphomastage III adult diffuse mixed cell lymphomastage III adult diffuse small cleaved cell lymphomastage IV adult diffuse large cell lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse small cleaved cell lymphomastage III adult Burkitt lymphomastage III adult immunoblastic large cell lymphomastage IV adult immunoblastic large cell lymphomastage III adult lymphoblastic lymphomastage IV adult lymphoblastic lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomastage III mantle cell lymphomastage IV mantle cell lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphomastage III marginal zone lymphomastage IV marginal zone lymphomastage III small lymphocytic lymphomastage IV small lymphocytic lymphomastage III mycosis fungoides/Sezary syndromestage IV mycosis fungoides/Sezary syndromecutaneous B-cell non-Hodgkin lymphomastage III cutaneous T-cell non-Hodgkin lymphomastage IV cutaneous T-cell non-Hodgkin lymphomastage III adult T-cell leukemia/lymphomastage IV adult T-cell leukemia/lymphomaanaplastic large cell lymphomaangioimmunoblastic T-cell lymphomaadult nasal type extranodal NK/T-cell lymphomaWaldenstrom macroglobulinemiaadult grade III lymphomatoid granulomatosisprimary central nervous system non-Hodgkin lymphomaintraocular lymphoma

Outcome Measures

Primary Outcomes (2)

  • Cell killing ability (positive or negative)

    Day 180

  • Percentage of cells killed

    Day 180

Interventions

immunological diagnostic methodOTHER
physiologic testingOTHER

Eligibility Criteria

AgeUp to 120 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Those with metastatic cancer OR healthy individuals with no prior cancer diagnosis and who are over the age of 50.

You may qualify if:

  • 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
  • +4 more criteria

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

Location

MeSH Terms

Conditions

NeoplasmsUrinary Bladder NeoplasmsColonic NeoplasmsCarcinoma, Non-Small-Cell LungPancreatic NeoplasmsRectal NeoplasmsCarcinoma, Renal CellMelanomaMultiple MyelomaSarcomaTesticular NeoplasmsBreast NeoplasmsCarcinoma, Ovarian EpithelialProstatic NeoplasmsEndometrial NeoplasmsOsteosarcomaBurkitt LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaLymphoma, FollicularLymphoma, Mantle-CellLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-CellMycosis FungoidesSezary SyndromeLymphoma, T-Cell, CutaneousPrecursor T-Cell Lymphoblastic Leukemia-LymphomaLymphoma, Large-Cell, AnaplasticImmunoblastic LymphadenopathyLymphoma, Extranodal NK-T-CellWaldenstrom MacroglobulinemiaIntraocular Lymphoma

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System DiseasesRectal DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeKidney NeoplasmsKidney DiseasesNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsSkin DiseasesSkin and Connective Tissue DiseasesNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesNeoplasms, Connective and Soft TissueGenital Neoplasms, MaleGenital Diseases, MaleGenital DiseasesTesticular DiseasesGonadal DisordersBreast DiseasesOvarian NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleGenital Neoplasms, FemaleProstatic DiseasesUterine NeoplasmsUterine DiseasesNeoplasms, Bone TissueNeoplasms, Connective TissueEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLymphomaLymphatic DiseasesLeukemia, LymphoidLeukemiaLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLymphoma, T-CellLymphadenopathyEye Neoplasms

Study Officials

  • Zheng Cui, PhD

    Wake Forest University Health Sciences

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2009

First Posted

May 12, 2009

Study Start

September 1, 2005

Primary Completion

October 23, 2009

Study Completion

October 23, 2009

Last Updated

May 30, 2017

Record last verified: 2017-04

Locations

US(1)