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Cause of Familial Testicular Cancer

StatusCompleted
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Amendment history

The 50 most recent of 267 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Minor

    Re-verified, no change to tracked fields

  2. Minor

    Eligibility criteria expanded, about 6 words

    Publications: details revised at 3 of 3 entries

    Show what changed: Eligibility criteria
    * INCLUSION CRITERIA: Study population: Patients must be membe [...] latives (at least one of which is testicular in origin), OR * a single family member with bilateral testicular cancer, * men with a history of TGCT who are one in a set of identical [...] etermined to have TGCT according to the following criteria: * Pathologic confirmation of a germ cell derived tumor arising [...] estis. Extragonadal germ cell tumors will also be included. * Germ cell derived histologies including: seminoma, germinoma [...] toma, choriocarcinoma, teratoma, and mixed germ cell tumor. * A case will be determined to have TIN on the basis [...]

  3. Minor

    36 amendments

    36 re-verifications since 2024-08-02, no change to tracked fields

    v230-v265

  4. Minor

    Trial status: Active, Not Recruiting to Completed

    Study Statusv229

  5. Minor

    Study Status, Arms and Interventions, Eligibility

    v228

Show 10 earlier versions

  1. Minor

    Eligibility criteria shortened, about 5 words

    Show what changed: Eligibility criteria
    [...] are eligible for this study include: i) all TGCT cases; ii) Allall GCT cases (including those of ovarian or extra-gonadal sites); iii) all first-degree relatives of each TGCTGCT case; iv) the spouse(s) of every case if the spouse and cas [...] wo cases; and vi) any blood relative with cancer other than TGCTGCT vii) family members as described in i) - v) above must be a [...] participation in this study if: There are not at least two provenconfirmed cases of GCT in the family, (at least one of which is testicular in origin), unless there is a family member with bilateral testicular [...] D lacking surviving spous [...]

    Study Status, Eligibilityv227

  2. Minor

    9 amendments

    9 re-verifications since 2023-12-15, no change to tracked fields

    v218-v226

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Background: People with a family history of testicular cancer may be at increased risk for the disease. Genetic and clinical studies of patients with testicular cancer and their family members may help clarify the cause of the disease and identify clinical features. Objectives: To characterize the clinical features of testicular cancer. To identify genes that may lead to increased risk of the disease. To examine emotional and behavioral issues of members of families at increased risk of the disease. Eligibility: Males and females from a family with at least two cases of testicular cancer in blood relatives. Males with testicular cancer in both testicles. Males with testicular cancer who have an identical twin. Participants must be at least 12 years of age. Design: Participants may take part in Part 1 or Parts 1 and 2 of this 2-part study. Part 1 participants: * Provide a blood or cheek cell sample to obtain DNA for gene studies. * Provide permission for researchers to obtain their medical records for review. * Complete questionnaires about their personal and family medical history, exposure to factors that might influence the risk of testicular cancer, and their feelings about being a member of a family in which several members have testicular cancer. * These data are collected from participants in their home communities. Part 2 participants: * All participants provide a medical history, have a complete physical examination, including routine lab tests, and have an ultrasound test of the abdomen to look at the kidneys. * Males have an ultrasound test of the testicles and scrotum. * Females have an ultrasound test of the pelvis to look at the ovaries, uterus and fallopian tubes. * Males 18 years of age and older provide a semen sample. * Some participants have computed tomography (CT) scanning of the chest, abdomen and pelvis instead of kidney ultrasound. Children under 18 years of age may have magnetic resonance imaging (MRI) instead of CT. * These data are collected from participants during a 2-day visit to the NIH Clinical Center in Bethesda, MD. Travel costs are covered by the protocol.
Trial Details
NCT Number NCT00034424
Lead Sponsor National Cancer Institute (NCI)
Conditions Testicular Cancer
Enrollment 749 participants
Start Date
Updated on ClinicalTrials.gov